+ All Categories
Home > Documents > Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by...

Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by...

Date post: 10-Sep-2020
Category:
Upload: others
View: 0 times
Download: 0 times
Share this document with a friend
318
Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged. 31 January 2019 EMA/662763/2018 Human Medicines Evaluation Division List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for olmesartan-containing medicinal products Referral under Article 31 of Directive 2001/83/EC for angiotensin-II-receptor antagonists (sartans) containing a tetrazole group Procedure number: EMEA/H/A-31/1471
Transcript
Page 1: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000

© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.

31 January 2019 EMA/662763/2018 Human Medicines Evaluation Division

List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for olmesartan-containing medicinal products

Referral under Article 31 of Directive 2001/83/EC for angiotensin-II-receptor antagonists (sartans) containing a tetrazole group

Procedure number: EMEA/H/A-31/1471

Page 2: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Austria Menarini International Operations Luxembourg S.A.

Amelior Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Austria Menarini International Operations Luxembourg S.A.

Amelior Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Austria Menarini International Operations Luxembourg S.A.

Amelior Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Austria Menarini International Operations Luxembourg S.A.

Amelior® Plus Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Menarini International Operations Luxembourg S.A.

Amelior® Plus Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Menarini International Operations Luxembourg S.A.

Amelior® Plus Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Menarini International Operations Luxembourg S.A.

Amelior® Plus Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 3: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 3/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Austria Menarini International Operations Luxembourg S.A.

Amelior® Plus Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Menarini International Operations Luxembourg S.A.

Mencord Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Menarini International Operations Luxembourg S.A.

Mencord Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Menarini International Operations Luxembourg S.A.

Mencord Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Menarini International Operations Luxembourg S.A.

Mencord Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Menarini International Operations Luxembourg S.A.

Mencord Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Austria Menarini International Operations Luxembourg S.A.

Mencord Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 4: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 4/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Austria Menarini International Operations Luxembourg S.A.

Mencord Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Austria Sandoz Gmbh Olmesartan Sandoz Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Austria Sandoz Gmbh Olmesartan Sandoz Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Austria Sandoz Gmbh Olmesartan Sandoz Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Austria Sandoz Gmbh Olmesartan/Amlodipin Sandoz

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Austria Sandoz Gmbh Olmesartan/Amlodipin Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Austria Sandoz Gmbh Olmesartan/Amlodipin Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Austria Sandoz Gmbh Olmesartan/Hct Sandoz Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Sandoz Gmbh Olmesartan/Hct Sandoz Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Sandoz Gmbh Olmesartan/Hct Sandoz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 5: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 5/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Austria Sandoz Gmbh Olmesartan/Hct Sandoz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Genericon Pharma Gesellschaft M.B.H.

Olmesarcomp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Genericon Pharma Gesellschaft M.B.H.

Olmesarcomp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Genericon Pharma Gesellschaft M.B.H.

Olmesarcomp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Genericon Pharma Gesellschaft M.B.H.

Olmesarcomp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Genericon Pharma Gesellschaft M.B.H.

Olmesartan Genericon Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Austria Genericon Pharma Gesellschaft M.B.H.

Olmesartan Genericon Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Austria Genericon Pharma Gesellschaft M.B.H.

Olmesartan Genericon Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Austria Arcana Arzneimittel Gmbh

Olmesartanmedoxomil/Amlodipin Mylan

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Austria Arcana Arzneimittel Gmbh

Olmesartanmedoxomil/Amlodipin Mylan

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Austria Arcana Arzneimittel Gmbh

Olmesartanmedoxomil/Amlodipin Mylan

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 6: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 6/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Austria Daiichi Sankyo Austria Gmbh

Sevikar Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 7: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 7/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Austria Daiichi Sankyo Austria Gmbh

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Olmesartan/Amlodipin Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Olmesartan/Amlodipin Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Olmesartan/Amlodipin Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Olmesartan/Amlodipin/Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Olmesartan/Amlodipin/Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Olmesartan/Amlodipin/Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Olmesartan/Amlodipin/Hct Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 8: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 8/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Austria Daiichi Sankyo Austria Gmbh

Olmesartan/Amlodipin/Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Austria Daiichi Sankyo Austria Gmbh

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Austria Actavis Group Ptc Ehf.

Olmesartan/Hct Actavis Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Actavis Group Ptc Ehf.

Olmesartan/Hct Actavis Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Actavis Group Ptc Ehf.

Olmesartan/Hct Actavis Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 9: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 9/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Austria Actavis Group Ptc Ehf.

Olmesartan/Hct Actavis Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Actavis Group Ptc Ehf.

Olmesartan Actavis Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Austria Actavis Group Ptc Ehf.

Olmesartan Actavis Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Austria Actavis Group Ptc Ehf.

Olmesartan Actavis Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Austria Actavis Group Ptc Ehf.

Olmesartan Actavis Olmesartan Medoxomil 5mg Tablet

Film-Coated Tablet Oral Use

Austria Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochlorothiazid Accord

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochlorothiazid Accord

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochlorothiazid Accord

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochlorothiazid Accord

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Accord Healthcare Limited

Olmesartan/Amlodipin Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Austria Accord Healthcare Limited

Olmesartan/Amlodipin Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 10: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 10/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Austria Accord Healthcare Limited

Olmesartan/Amlodipin Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Austria Accord Healthcare Limited

Olmesartanmedoxomil Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Austria Accord Healthcare Limited

Olmesartanmedoxomil Accord

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Austria Accord Healthcare Limited

Olmesartanmedoxomil Accord

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Austria G.L. Pharma Gmbh Olmeblo Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Austria G.L. Pharma Gmbh Olmeblo Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Austria G.L. Pharma Gmbh Olmeblo Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Austria G.L. Pharma Gmbh Olmeblo Olmesartan Medoxomil 5mg Tablet

Film-Coated Tablet Oral Use

Austria G.L. Pharma Gmbh Olmeblo Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria G.L. Pharma Gmbh Olmeblo Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria G.L. Pharma Gmbh Olmeblo Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 11: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 11/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Austria G.L. Pharma Gmbh Olmeblo Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria G.L. Pharma Gmbh Amlocor Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 5mg Tablet

Film-Coated Tablet Oral Use

Austria G.L. Pharma Gmbh Amlocor Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 10mg Tablet

Film-Coated Tablet Oral Use

Austria G.L. Pharma Gmbh Amlocor Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 5mg Tablet

Film-Coated Tablet Oral Use

Austria 1a Pharma Gmbh Olmesartan/Amlodipin 1a Pharma

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Austria 1a Pharma Gmbh Olmesartan/Amlodipin 1a Pharma

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Austria 1a Pharma Gmbh Olmesartan/Amlodipin 1a Pharma

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Austria 1a Pharma Gmbh Olmesartan/Hct 1a Pharma Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria 1a Pharma Gmbh Olmesartan/Hct 1a Pharma Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria 1a Pharma Gmbh Olmesartan/Hct 1a Pharma Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 12: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 12/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Austria 1a Pharma Gmbh Olmesartan/Hct 1a Pharma Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria 1a Pharma Gmbh Olmesartan 1a Pharma Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Austria 1a Pharma Gmbh Olmesartan 1a Pharma Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Austria 1a Pharma Gmbh Olmesartan 1a Pharma Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Austria Teva B.V Olmesartan Ratiopharm Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Austria Teva B.V Olmesartan Ratiopharm Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Austria Teva B.V Olmesartan Ratiopharm Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Austria Teva B.V Olmesartan/Amlodipin Ratiopharm

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Austria Teva B.V Olmesartan/Amlodipin Ratiopharm

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Austria Teva B.V Olmesartan/Amlodipin Ratiopharm

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Austria Teva B.V Olmesartan/Hct Ratiopharm Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Teva B.V Olmesartan/Hct Ratiopharm Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 13: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 13/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Austria Teva B.V Olmesartan/Hct Ratiopharm Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Teva B.V Olmesartan/Hct Ratiopharm Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Krka, D.D., Novo Mesto

Olmesartan Krka Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Austria Krka, D.D., Novo Mesto

Olmesartan Krka Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Austria Krka, D.D., Novo Mesto

Olmesartan Krka Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Austria Krka, D.D., Novo Mesto

Olmesartan/Hct Krka Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Krka, D.D., Novo Mesto

Olmesartan/Hct Krka Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Krka, D.D., Novo Mesto

Olmesartan/Hct Krka Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Austria Krka, D.D., Novo Mesto

Olmesartan/Hct Krka Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Austria Krka, D.D., Novo Mesto

Olmesartan/Amlodipin Krka Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 14: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 14/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Austria Krka, D.D., Novo Mesto

Olmesartan/Amlodipin Krka Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Austria Krka, D.D., Novo Mesto

Olmesartan/Amlodipin Krka Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Belsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Belsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Belsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Belsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 15: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 15/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Belgium Menarini International Operations Luxembourg S.A.

Forzaten Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 16: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 16/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Belgium Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 17: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 17/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Belgium Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 18: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 18/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Belgium Menarini International Operations Luxembourg S.A.

Forzaten Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Forzaten Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Belsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Belsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Belsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Belsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Belsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 19: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 19/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Belgium Menarini International Operations Luxembourg S.A.

Belsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Belsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Belsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Belsar Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Belsar Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Belsar Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Belsar Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 20: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 20/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Belgium Menarini International Operations Luxembourg S.A.

Belsar Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Belsar Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Belsar Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Belsar Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Belgium Menarini International Operations Luxembourg S.A.

Belsar Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Belgium Aurobindo Pharma B.V.

Co‐olmesartan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Aurobindo Pharma B.V.

Co-Olmesartan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 21: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 21/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Belgium Aurobindo Pharma B.V.

Co‐olmesartan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Aurobindo Pharma B.V.

Co‐olmesartan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Aurobindo Pharma B.V.

Co‐olmesartan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Aurobindo Pharma B.V.

Co-Olmesartan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Aurobindo Pharma B.V.

Co‐olmesartan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Aurobindo Pharma B.V.

Co-Olmesartan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Hcs Bvba Olmesartan/Amlodipine Hcs Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Hcs Bvba Olmesartan/Amlodipine Hcs Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Hcs Bvba Olmesartan/Amlodipine Hcs Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan Eg Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 22: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 22/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Belgium Eurogenerics N.V./S.A.

Olmesartan Eg Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan Eg Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan Eg Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan Eg Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan Eg Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan Eg Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan Eg Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan Eg Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan Plus Hct Eg Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan Plus Hct Eg Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan Plus Hct Eg Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 23: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 23/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Belgium Eurogenerics N.V./S.A.

Olmesartan Plus Hct Eg Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan Plus Hct Eg Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan Plus Hct Eg Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan Plus Hct Eg Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan Plus Hct Eg Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan Plus Hct Eg Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan Plus Hct Eg Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan Plus Hct Eg Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan Plus Hct Eg Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 24: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 24/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Belgium Eurogenerics N.V./S.A.

Olmesartan/Amlodipine Eg Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan/Amlodipine Eg Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan/Amlodipine Eg Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan/Amlodipine Eg Amlodipine 10mg Tablet, Olmesartan 40mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan/Amlodipine Eg Amlodipine 10mg Tablet, Olmesartan 40mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan/Amlodipine Eg Amlodipine 10mg Tablet, Olmesartan 40mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan/Amlodipine Eg Amlodipine 5mg Tablet, Olmesartan 40mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan/Amlodipine Eg Amlodipine 5mg Tablet, Olmesartan 40mg Tablet

Film-Coated Tablet Oral Use

Belgium Eurogenerics N.V./S.A.

Olmesartan/Amlodipine Eg Amlodipine 5mg Tablet, Olmesartan 40mg Tablet

Film-Coated Tablet Oral Use

Belgium Teva Pharma Belgium N.V./S.A

Olmesartan Teva Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Teva Pharma Belgium N.V./S.A

Olmesartan Teva Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Belgium Teva Pharma Belgium N.V./S.A

Olmesartan Teva Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Belgium Teva Pharma Belgium N.V./S.A

Olmesartan/Amlodipine Teva Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 25: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 25/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Belgium Teva Pharma Belgium N.V./S.A

Olmesartan/Amlodipine Teva Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Teva Pharma Belgium N.V./S.A

Olmesartan/Amlodipine Teva Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Teva Pharma Belgium N.V./S.A

Olmesartan/Amlodipine Teva Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Teva Pharma Belgium N.V./S.A

Olmesartan/Amlodipine Teva Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Teva Pharma Belgium N.V./S.A

Olmesartan/Amlodipine Teva Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Teva Pharma Belgium N.V./S.A

Olmesartan/Amlodipine Teva Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Teva Pharma Belgium N.V./S.A

Olmesartan/Amlodipine Teva Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Teva Pharma Belgium N.V./S.A

Olmesartan/Amlodipine Teva Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 26: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 26/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Belgium Daiichi Sankyo Belgium S.A

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Sevikar/Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Sevikar/Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 27: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 27/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Belgium Daiichi Sankyo Belgium S.A

Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan Daiichi Sankyo Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan Daiichi Sankyo Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 28: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 28/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Belgium Daiichi Sankyo Belgium S.A

Olmesartan Daiichi Sankyo Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan Hct Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan Hct Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan Hct Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan Hct Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan Daiichi Sankyo Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 29: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 29/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Belgium Daiichi Sankyo Belgium S.A

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan Daiichi Sankyo Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan Daiichi Sankyo Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan/Amlodipine/Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan/Amlodipine/Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan/Amlodipine/Hct Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 30: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 30/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Belgium Daiichi Sankyo Belgium S.A

Olmesartan/Amlodipine/Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan/Amlodipine/Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan/Amlodipine Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan/Amlodipine Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmesartan/Amlodipine Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 31: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 31/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Belgium Daiichi Sankyo Belgium S.A

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Daiichi Sankyo Belgium S.A

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Sandoz N.V. Olmesartan/Amlodipin Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Sandoz N.V. Olmesartan/Amlodipine Sandoz

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Sandoz N.V. Olmesartan/Amlodipine Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Sandoz N.V. Olmesartan Sandoz Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Sandoz N.V. Olmesartan Sandoz Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Belgium Sandoz N.V. Olmesartan Sandoz Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 32: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 32/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Belgium Sandoz N.V. Co-Olmesartan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Sandoz N.V. Co-Olmesartan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Sandoz N.V. Co-Olmesartan Sandoz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Sandoz N.V. Co-Olmesartan Sandoz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Sandoz N.V. Co-Olmesartan Sandoz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Sandoz N.V. Co-Olmesartan Sandoz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Krka, D.D., Novo Mesto

Olmesartan/Amlodipine Krka Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Krka, D.D., Novo Mesto

Olmesartan/Amlodipine Krka Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Krka, D.D., Novo Mesto

Olmesartan/Amlodipine Krka Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Belgium Krka, D.D., Novo Mesto

Olmesartan/Hctz Krka Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 33: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 33/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Belgium Krka, D.D., Novo Mesto

Olmesartan/Hctz Krka Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Krka, D.D., Novo Mesto

Olmesartan/Hctz Krka Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Belgium Krka, D.D., Novo Mesto

Olmesartan/Hctz Krka Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Belgium Krka, D.D., Novo Mesto

Olmesartan Krka Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Belgium Krka, D.D., Novo Mesto

Olmesartan Krka Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Belgium Krka, D.D., Novo Mesto

Olmesartan Krka Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Menarini International Operations Luxembourg S.A.

Теспадан Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Menarini International Operations Luxembourg S.A.

Теспадан Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Menarini International Operations Luxembourg S.A.

Теспадан Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 34: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 34/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Bulgaria Menarini International Operations Luxembourg S.A.

Теспадан Нст Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Menarini International Operations Luxembourg S.A.

Теспадан Нст Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Menarini International Operations Luxembourg S.A.

Теспадан Нст Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Menarini International Operations Luxembourg S.A.

Теспадан Нст Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Menarini International Operations Luxembourg S.A.

Теспадан Нст Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Menarini International Operations Luxembourg S.A.

Тенсар Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Menarini International Operations Luxembourg S.A.

Тенсар Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 35: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 35/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Bulgaria Menarini International Operations Luxembourg S.A.

Тенсар Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Teva Pharmaceuticals Bulgaria Eood

Олместа Плюс Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Teva Pharmaceuticals Bulgaria Eood

Олместа Плюс Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Teva Pharmaceuticals Bulgaria Eood

Олместа Плюс Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Teva Pharmaceuticals Bulgaria Eood

Олместа Плюс Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Mc Pharma Ad Неосара Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Mc Pharma Ad Неосара Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Mc Pharma Ad Неосара-Ко Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Mc Pharma Ad Неосара-Ко Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 36: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 36/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Bulgaria Mylan Eood Олмесартан/Hctz Майлан Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 13mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Mylan Eood Олмесартан/Hctz Майлан Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 13mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Spm Bulgaria Ood Олмезид Am Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Spm Bulgaria Ood Олмезид Am Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Spm Bulgaria Ood Олмезид Am Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Tchaikapharma High Quality Medicines, Inc.

Olsart Olmesartan Medoxomil 10mg Tablet

Film Coated Tablet Oral Use

Bulgaria Tchaikapharma High Quality Medicines, Inc.

Olsart Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Tchaikapharma High Quality Medicines, Inc.

Olsart Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Tchaikapharma High Quality Medicines, Inc.

Коолсарт Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Tchaikapharma High Quality Medicines, Inc.

Коолсарт Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 37: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 37/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Bulgaria Tchaikapharma High Quality Medicines, Inc.

Коолсарт Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Tchaikapharma High Quality Medicines, Inc.

Коолсарт Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Actavis Group Ptc Ehf.

Vivactra Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Actavis Group Ptc Ehf.

Vivactra Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Accord Healthcare Limited

Олмесартан Медоксомил/Амлодипин Акорд

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Accord Healthcare Limited

Олмесартан Медоксомил/Амлодипин Акорд

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Stada Arzneimittel Ag

Олмезид Плюс Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Stada Arzneimittel Ag

Олмезид Плюс Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Generics [uk] Limited Олмедипин Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 38: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 38/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Bulgaria Generics [uk] Limited Олмедипин Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Teva B.V Олместа А Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Teva B.V Олместа А Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Teva B.V Олместа Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Teva B.V Олместа Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Aurobindo Pharma (Malta) Limited

Олмесартан/ Хидрохлоротиазид Ауробиндо

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Aurobindo Pharma (Malta) Limited

Олмесартан/ Хидрохлоротиазид Ауробиндо

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Aurobindo Pharma (Malta) Limited

Олмесартан/ Хидрохлоротиазид Ауробиндо

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Aurobindo Pharma (Malta) Limited

Олмесартан/ Хидрохлоротиазид Ауробиндо

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Sandoz Pharmaceuticals D.D.

Tansidor Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Sandoz Pharmaceuticals D.D.

Tansidor Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 39: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 39/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Bulgaria Sandoz Pharmaceuticals D.D.

Tansidor Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Sandoz Pharmaceuticals D.D.

Танзидор Дуо Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Sandoz Pharmaceuticals D.D.

Танзидор Дуо Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Sandoz Pharmaceuticals D.D.

Танзидор Дуо Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Sandoz Pharmaceuticals D.D.

Танзидор Н Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Sandoz Pharmaceuticals D.D.

Танзидор Н Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Krka, D.D., Novo Mesto

Ко-Олиместра Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Krka, D.D., Novo Mesto

Ко-Олиместра Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Krka, D.D., Novo Mesto

Ко-Олиместра Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12500μg Tablet

Film-Coated Tablet Oral Use

Bulgaria Krka, D.D., Novo Mesto

Ко-Олиместра Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 40: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 40/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Bulgaria Krka, D.D., Novo Mesto

Олмита Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Krka, D.D., Novo Mesto

Олмита Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Krka, D.D., Novo Mesto

Олмита Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Krka, D.D., Novo Mesto

Олиместра Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Krka, D.D., Novo Mesto

Олиместра Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Bulgaria Krka, D.D., Novo Mesto

Олиместра Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Croatia Genericon Pharma Gesellschaft M.B.H.

Olmesartan Genericon Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Croatia Genericon Pharma Gesellschaft M.B.H.

Olmesartan Genericon Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Croatia Genericon Pharma Gesellschaft M.B.H.

Olmesartan Genericon Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Croatia Genericon Pharma Gesellschaft M.B.H.

Olmesartan/Hidroklorotiazid Genericon

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Croatia Genericon Pharma Gesellschaft M.B.H.

Olmesartan/Hidroklorotiazid Genericon

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Croatia Genericon Pharma Gesellschaft M.B.H.

Olmesartan/Hidroklorotiazid Genericon

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 41: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 41/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Croatia Genericon Pharma Gesellschaft M.B.H.

Olmesartan/Hidroklorotiazid Genericon

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Croatia Krka-Farma D.O.O. Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Croatia Krka-Farma D.O.O. Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Croatia Krka-Farma D.O.O. Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Croatia Krka-Farma D.O.O. Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Croatia Krka-Farma D.O.O. Olimestra Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Croatia Krka-Farma D.O.O. Olimestra Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Croatia Krka-Farma D.O.O. Olimestra Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Croatia Krka-Farma D.O.O. Olmita Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Croatia Krka-Farma D.O.O. Olmita Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Croatia Krka-Farma D.O.O. Olmita Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 42: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 42/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Cyprus Menarini International Operations Luxembourg S.A.

Olartan-Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Cyprus Menarini International Operations Luxembourg S.A.

Olartan-Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Cyprus Menarini International Operations Luxembourg S.A.

Orizal Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Cyprus Menarini International Operations Luxembourg S.A.

Orizal Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Cyprus Menarini International Operations Luxembourg S.A.

Orizal Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Cyprus Menarini International Operations Luxembourg S.A.

Orizal Plus Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Cyprus Menarini International Operations Luxembourg S.A.

Orizal Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 43: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 43/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Cyprus Menarini International Operations Luxembourg S.A.

Orizal Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Cyprus Menarini International Operations Luxembourg S.A.

Orizal Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Cyprus Menarini International Operations Luxembourg S.A.

Orizal Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Cyprus Menarini International Operations Luxembourg S.A.

Olartan-Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Cyprus Menarini International Operations Luxembourg S.A.

Olartan-Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Cyprus Menarini International Operations Luxembourg S.A.

Olartan Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Cyprus Menarini International Operations Luxembourg S.A.

Olartan Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 44: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 44/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Cyprus Menarini International Operations Luxembourg S.A.

Olartan Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Cyprus Sanofi-Aventis Cyprus Ltd

Olmesartan+hct Zentiva Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Cyprus Sanofi-Aventis Cyprus Ltd

Olmesartan+hct Zentiva Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Cyprus Sanofi-Aventis Cyprus Ltd

Olmesartan+hct Zentiva Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Cyprus Sanofi-Aventis Cyprus Ltd

Olmesartan+hct Zentiva Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Cyprus Jubilant Pharmaceuticals Nv

Olmesartan Medoxomil Jubilant

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Cyprus Jubilant Pharmaceuticals Nv

Olmesartan Medoxomil Jubilant

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Cyprus Jubilant Pharmaceuticals Nv

Olmesartan Medoxomil Jubilant

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Cyprus Tad Pharma Gmbh Olmesartan/Hydrochlorothiazide Tad

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 45: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 45/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Cyprus Tad Pharma Gmbh Olmesartan/Hydrochlorothiazide Tad

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Cyprus Tad Pharma Gmbh Olmesartan/Hydrochlorothiazide Tad

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Cyprus Tad Pharma Gmbh Olmesartan/Hydrochlorothiazide Tad

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Menarini International Operations Luxembourg S.A.

Sarten Plus H Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Menarini International Operations Luxembourg S.A.

Sarten Plus H Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Menarini International Operations Luxembourg S.A.

Sintonyn Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Menarini International Operations Luxembourg S.A.

Sintonyn Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 46: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 46/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Czech Republic Menarini International Operations Luxembourg S.A.

Sintonyn Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Menarini International Operations Luxembourg S.A.

Sintonyn Combi Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Menarini International Operations Luxembourg S.A.

Sintonyn Combi Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Menarini International Operations Luxembourg S.A.

Sintonyn Combi Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Menarini International Operations Luxembourg S.A.

Sintonyn Combi Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Menarini International Operations Luxembourg S.A.

Sintonyn Combi Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Menarini International Operations Luxembourg S.A.

Sarten Plus H Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 47: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 47/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Czech Republic Menarini International Operations Luxembourg S.A.

Sarten Plus H Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Menarini International Operations Luxembourg S.A.

Sarten Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Menarini International Operations Luxembourg S.A.

Sarten Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Menarini International Operations Luxembourg S.A.

Sarten Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Apotex Europe B.V. Olmesartan Apotex Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Apotex Europe B.V. Olmesartan Apotex Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Apotex Europe B.V. Olmesartan Apotex Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Zentiva, K.S. Zeota Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Zentiva, K.S. Zeota Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 48: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 48/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Czech Republic Zentiva, K.S. Zeota Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Zentiva, K.S. Zeota Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Zentiva, K.S. Zeota Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Zentiva, K.S. Zeota Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Zentiva, K.S. Zeota Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Zentiva, K.S. Olmesartan/Amlodipin Zentiva

Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 6.95mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Zentiva, K.S. Olmesartan/Amlodipin Zentiva

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 13.89mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Zentiva, K.S. Olmesartan/Amlodipin Zentiva

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 6.95mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Krka, D.D., Novo Mesto

Olimesta Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Krka, D.D., Novo Mesto

Olimesta Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 49: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 49/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Czech Republic Krka, D.D., Novo Mesto

Olimesta Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Krka, D.D., Novo Mesto

Olimesta Combi Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Krka, D.D., Novo Mesto

Olimesta Combi Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Krka, D.D., Novo Mesto

Olimesta Combi Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Krka, D.D., Novo Mesto

Olimesta Combi Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Krka, D.D., Novo Mesto

Olmesartan/Amlodipine Krka Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Krka, D.D., Novo Mesto

Olmesartan/Amlodipine Krka Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Krka, D.D., Novo Mesto

Olmesartan/Amlodipine Krka Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Krka, D.D., Novo Mesto

Olssa Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Krka, D.D., Novo Mesto

Olssa Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Czech Republic Krka, D.D., Novo Mesto

Olssa Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 50: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 50/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Denmark Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Denmark Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Denmark Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Denmark Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Denmark Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Denmark Menarini International Operations Luxembourg S.A.

Alea Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Denmark Menarini International Operations Luxembourg S.A.

Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 51: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 51/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Denmark Menarini International Operations Luxembourg S.A.

Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Denmark Menarini International Operations Luxembourg S.A.

Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Denmark Menarini International Operations Luxembourg S.A.

Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Denmark Menarini International Operations Luxembourg S.A.

Benetor Comp. Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Denmark Menarini International Operations Luxembourg S.A.

Benetor Comp. Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Denmark Menarini International Operations Luxembourg S.A.

Benetor Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Denmark Menarini International Operations Luxembourg S.A.

Benetor Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 52: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 52/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Denmark Menarini International Operations Luxembourg S.A.

Benetor Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Denmark Jubilant Pharmaceuticals Nv

Olmesartan Jubilant Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Denmark Jubilant Pharmaceuticals Nv

Olmesartan Jubilant Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Denmark Jubilant Pharmaceuticals Nv

Olmesartan Jubilant Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Denmark Krka Sverige Ab Olimesta Combi Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12500μg Tablet

Film-Coated Tablet Oral Use

Denmark Krka Sverige Ab Olimesta Combi Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Denmark Krka Sverige Ab Olimesta Combi Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12500μg Tablet

Film-Coated Tablet Oral Use

Denmark Krka Sverige Ab Olimesta Combi Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Denmark Krka Sverige Ab Olimesta Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Denmark Krka Sverige Ab Olimesta Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 53: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 53/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Denmark Krka Sverige Ab Olimesta Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Denmark Daiichi Sankyo Europe Gmbh

Sevikar Comp Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Denmark Daiichi Sankyo Europe Gmbh

Sevikar Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Denmark Daiichi Sankyo Europe Gmbh

Sevikar Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Denmark Daiichi Sankyo Europe Gmbh

Sevikar Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Denmark Daiichi Sankyo Europe Gmbh

Sevikar Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Denmark Daiichi Sankyo Europe Gmbh

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Denmark Daiichi Sankyo Europe Gmbh

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 54: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 54/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Denmark Daiichi Sankyo Europe Gmbh

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Denmark Daiichi Sankyo Europe Gmbh

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Denmark Daiichi Sankyo Europe Gmbh

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Denmark Daiichi Sankyo Europe Gmbh

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Denmark Daiichi Sankyo Europe Gmbh

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Denmark Daiichi Sankyo Europe Gmbh

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Denmark Daiichi Sankyo Europe Gmbh

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Denmark Daiichi Sankyo Europe Gmbh

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Denmark Krka, D.D., Novo Mesto

Combidiur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Denmark Krka, D.D., Novo Mesto

Combidiur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 55: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 55/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Denmark Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Denmark Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Denmark Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Denmark Krka, D.D., Novo Mesto

Olmedie Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Denmark Krka, D.D., Novo Mesto

Olmedie Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Denmark Krka, D.D., Novo Mesto

Olmedie Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Denmark Krka, D.D., Novo Mesto

Olmesartan Medoxomil/Hydrochlorothiazide Krka

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Denmark Krka, D.D., Novo Mesto

Olmesartan Medoxomil/Hydrochlorothiazide Krka

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Denmark Krka, D.D., Novo Mesto

Olmesartan Medoxomil/Hydrochlorothiazide Krka

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Denmark Krka, D.D., Novo Mesto

Olmesartan Medoxomil/Hydrochlorothiazide Krka

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Denmark Krka, D.D., Novo Mesto

Olmesartan Medoxomil Krka Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 56: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 56/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Denmark Krka, D.D., Novo Mesto

Olmesartan Medoxomil Krka Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Denmark Krka, D.D., Novo Mesto

Olmesartan Medoxomil Krka Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Estonia Menarini International Operations Luxembourg S.A.

Mesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Estonia Menarini International Operations Luxembourg S.A.

Mesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Estonia Menarini International Operations Luxembourg S.A.

Sanoral Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Estonia Menarini International Operations Luxembourg S.A.

Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Estonia Menarini International Operations Luxembourg S.A.

Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 57: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 57/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Estonia Menarini International Operations Luxembourg S.A.

Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Estonia Menarini International Operations Luxembourg S.A.

Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Estonia Menarini International Operations Luxembourg S.A.

Sanoral Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Estonia Menarini International Operations Luxembourg S.A.

Sanoral Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Estonia Menarini International Operations Luxembourg S.A.

Sanoral Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Estonia Menarini International Operations Luxembourg S.A.

Mesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Estonia Menarini International Operations Luxembourg S.A.

Mesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 58: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 58/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Estonia Menarini International Operations Luxembourg S.A.

Mesar Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Estonia Menarini International Operations Luxembourg S.A.

Mesar Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Estonia Menarini International Operations Luxembourg S.A.

Mesar Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Estonia Apotex Europe B.V. Olmesartan Medoxomil Apotex

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Estonia Apotex Europe B.V. Olmesartan Medoxomil Apotex

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Estonia Apotex Europe B.V. Olmesartan Medoxomil Apotex

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Estonia Apotex Europe B.V. Olmesartan Medoxomil/Hydrochlorothiazide Apotex

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Estonia Apotex Europe B.V. Olmesartan Medoxomil/Hydrochlorothiazide Apotex

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Estonia Apotex Europe B.V. Olmesartan Medoxomil/Hydrochlorothiazide Apotex

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 59: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 59/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Estonia Apotex Europe B.V. Olmesartan Medoxomil/Hydrochlorothiazide Apotex

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Estonia Genericon Pharma Gesellschaft M.B.H.

Olmesartan Medoxomil/Hct Genericon

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Estonia Genericon Pharma Gesellschaft M.B.H.

Olmesartan Medoxomil/Hct Genericon

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Estonia Genericon Pharma Gesellschaft M.B.H.

Olmesartan Medoxomil/Hct Genericon

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Estonia Genericon Pharma Gesellschaft M.B.H.

Olmesartan Medoxomil/Hct Genericon

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Estonia Alembic Pharmaceuticals Europe Ltd

Olmesartan Medoxomil Alembic

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Estonia Alembic Pharmaceuticals Europe Ltd

Olmesartan Medoxomil Alembic

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Estonia Alembic Pharmaceuticals Europe Ltd

Olmesartan Medoxomil Alembic

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Estonia Alembic Pharmaceuticals Europe Ltd

Olmesartan Medoxomil/Hydrochlorothiazide Alembic

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 60: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 60/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Estonia Alembic Pharmaceuticals Europe Ltd

Olmesartan Medoxomil/Hydrochlorothiazide Alembic

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Estonia Alembic Pharmaceuticals Europe Ltd

Olmesartan Medoxomil/Hydrochlorothiazide Alembic

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Estonia Alembic Pharmaceuticals Europe Ltd

Olmesartan Medoxomil/Hydrochlorothiazide Alembic

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Estonia Actavis Group Ptc Ehf.

Vivactra Olmesartan Medoxomil 5mg Tablet

Film-Coated Tablet Oral Use

Estonia Actavis Group Ptc Ehf.

Vivactra Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Estonia Actavis Group Ptc Ehf.

Vivactra Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Estonia Actavis Group Ptc Ehf.

Vivactra Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Estonia Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Estonia Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Estonia Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 61: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 61/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Estonia Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Estonia Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Estonia Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Estonia Teva B.V Olmesartan Medoxomil/Amlodipine Teva

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Estonia Teva B.V Olmesartan Medoxomil/Amlodipine Teva

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Estonia Zentiva, K.S. Olmesartan Medoxomil/Amlodipine Zentiva

Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 6.95mg Tablet

Film-Coated Tablet Oral Use

Estonia Zentiva, K.S. Olmesartan Medoxomil/Amlodipine Zentiva

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 13.89mg Tablet

Film-Coated Tablet Oral Use

Estonia Zentiva, K.S. Olmesartan Medoxomil/Amlodipine Zentiva

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 6.95mg Tablet

Film-Coated Tablet Oral Use

Estonia Sandoz Pharmaceuticals D.D.

Olmesartan Medoxomil/Amlodipine Sandoz

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Estonia Sandoz Pharmaceuticals D.D.

Olmesartan Medoxomil/Amlodipine Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 62: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 62/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Estonia Sandoz Pharmaceuticals D.D.

Olmesartan Medoxomil/Amlodipine Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Estonia Doc Generici S.R.L. Olmesartan Medoxomil Doc Generici

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Estonia Doc Generici S.R.L. Olmesartan Medoxomil Doc Generici

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Estonia Doc Generici S.R.L. Olmesartan Medoxomil Doc Generici

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Estonia Doc Generici S.R.L. Olmesartan Hct Sigillata Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film Coated Tablet Oral Use

Estonia Doc Generici S.R.L. Olmesartan Hct Sigillata Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film Coated Tablet Oral Use

Estonia Doc Generici S.R.L. Olmesartan Hct Sigillata Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film Coated Tablet Oral Use

Estonia Doc Generici S.R.L. Olmesartan Hct Sigillata Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film Coated Tablet Oral Use

Estonia Doc Generici S.R.L. Olmesartan Hct Sigillata Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film Coated Tablet Oral Use

Estonia Doc Generici S.R.L. Olmesartan Hct Sigillata Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film Coated Tablet Oral Use

Page 63: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 63/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Estonia Doc Generici S.R.L. Olmesartan Hct Sigillata Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film Coated Tablet Oral Use

Estonia Doc Generici S.R.L. Olmesartan Hct Sigillata Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film Coated Tablet Oral Use

Estonia Doc Generici S.R.L. Olmesartan Hct Sigillata Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film Coated Tablet Oral Use

Estonia Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12500μg Tablet

Film-Coated Tablet Oral Use

Estonia Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Estonia Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Estonia Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Estonia Krka, D.D., Novo Mesto

Olssa Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Estonia Krka, D.D., Novo Mesto

Olssa Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Estonia Krka, D.D., Novo Mesto

Olssa Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 64: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 64/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Estonia Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Estonia Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Estonia Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Alea Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Alea Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 65: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 65/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Finland Menarini International Operations Luxembourg S.A.

Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 66: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 66/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Finland Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 67: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 67/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Finland Menarini International Operations Luxembourg S.A.

Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Benetor Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Benetor Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Benetor Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Benetor Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Benetor Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Benetor Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 68: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 68/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Finland Menarini International Operations Luxembourg S.A.

Benetor Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Benetor Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Benetor Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Finland Menarini International Operations Luxembourg S.A.

Benetor Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Finland Sandoz A/S Olmesartan Medoxomil Sandoz

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Finland Sandoz A/S Olmesartan Medoxomil Sandoz

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Finland Sandoz A/S Olmesartan Medoxomil Sandoz

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Finland Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 69: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 69/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Finland Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Finland Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Finland Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Finland Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Finland Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Finland Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochlorothiazide Accord

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Finland Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochlorothiazide Accord

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Finland Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochlorothiazide Accord

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Finland Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochlorothiazide Accord

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Finland Stada Arzneimittel Ag

Olmesartan Medoxomil Stada

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 70: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 70/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Finland Stada Arzneimittel Ag

Olmesartan Medoxomil Stada

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Finland Stada Arzneimittel Ag

Olmesartan Medoxomil Stada

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Finland Stada Arzneimittel Ag

Olmestad Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Finland Stada Arzneimittel Ag

Olmestad Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Finland Daiichi Sankyo Europe Gmbh

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Finland Daiichi Sankyo Europe Gmbh

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Finland Daiichi Sankyo Europe Gmbh

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Finland Daiichi Sankyo Europe Gmbh

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Finland Daiichi Sankyo Europe Gmbh

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Finland Daiichi Sankyo Europe Gmbh

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Finland Daiichi Sankyo Europe Gmbh

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 71: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 71/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Finland Daiichi Sankyo Europe Gmbh

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Finland Daiichi Sankyo Europe Gmbh

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Finland Daiichi Sankyo Europe Gmbh

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Finland Krka, D.D., Novo Mesto

Olmesartan Medoxomil/Amlodipine Krka

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Finland Krka, D.D., Novo Mesto

Olmesartan Medoxomil/Amlodipine Krka

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Finland Krka, D.D., Novo Mesto

Olmesartan Medoxomil/Amlodipine Krka

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Finland Krka, D.D., Novo Mesto

Olmesartan Medoxomil/Hydrochlorothiazide Krka

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Finland Krka, D.D., Novo Mesto

Olmesartan Medoxomil/Hydrochlorothiazide Krka

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Finland Krka, D.D., Novo Mesto

Olmesartan Medoxomil Krka Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Finland Krka, D.D., Novo Mesto

Olmesartan Medoxomil Krka Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Finland Krka, D.D., Novo Mesto

Olmesartan Medoxomil Krka Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 72: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 72/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

France Menarini International Operations Luxembourg S.A.

Alteisduo Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

France Menarini International Operations Luxembourg S.A.

Alteisduo Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

France Menarini International Operations Luxembourg S.A.

Axeler Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 6.944mg Tablet

Film-Coated Tablet Oral Use

France Menarini International Operations Luxembourg S.A.

Axeler Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 13.888mg Tablet

Film-Coated Tablet Oral Use

France Menarini International Operations Luxembourg S.A.

Axeler Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 6.944mg Tablet

Film-Coated Tablet Oral Use

France Menarini International Operations Luxembourg S.A.

Alteisduo Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

France Menarini International Operations Luxembourg S.A.

Alteisduo Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 73: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 73/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

France Menarini International Operations Luxembourg S.A.

Alteis Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

France Menarini International Operations Luxembourg S.A.

Alteis Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

France Menarini International Operations Luxembourg S.A.

Alteis Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 6.944mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 13.888mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 6.944mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Coolmetec Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Coolmetec Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 74: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 74/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

France Daiichi Sankyo France Sas

Coolmetec Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Coolmetec Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Coolmetec Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Coolmetec Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Coolmetec Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Coolmetec Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Coolmetec Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Coolmetec Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Coolmetec Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 75: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 75/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

France Daiichi Sankyo France Sas

Coolmetec Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

France Daiichi Sankyo France Sas

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

France Zydus France Olmesartan Medoxomil Zydus

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

France Zydus France Olmesartan Medoxomil Zydus

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

France Zydus France Olmesartan Medoxomil Zydus

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

France Zydus France Olmesartan Medoxomil Zydus

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

France Zydus France Olmesartan Medoxomil Zydus

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 76: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 76/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

France Zydus France Olmesartan Medoxomil Zydus

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

France Zydus France Olmesartan Medoxomil Zydus

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

France Zydus France Olmesartan Medoxomil Zydus

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

France Zydus France Olmesartan Medoxomil Zydus

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Germany Menarini International Operations Luxembourg S.A.

Vocado Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Menarini International Operations Luxembourg S.A.

Vocado Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Germany Menarini International Operations Luxembourg S.A.

Vocado Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Menarini International Operations Luxembourg S.A.

Vocado Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 77: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 77/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Germany Menarini International Operations Luxembourg S.A.

Vocado Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Menarini International Operations Luxembourg S.A.

Vocado Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Menarini International Operations Luxembourg S.A.

Vocado Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Menarini International Operations Luxembourg S.A.

Vocado Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Substipharm Developpement

Miradizan Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Germany Substipharm Developpement

Miradizan Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Germany Substipharm Developpement

Miradizan Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Germany Astron Research Limited

Olmesartanmedoxomil/Amlodipin Astron

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Astron Research Limited

Olmesartanmedoxomil/Amlodipin Astron

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 78: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 78/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Germany Astron Research Limited

Olmesartanmedoxomil/Amlodipin Astron

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Berlin-Chemie Ag Votum Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Berlin-Chemie Ag Votum Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Berlin-Chemie Ag Votum Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Berlin-Chemie Ag Votum Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Berlin-Chemie Ag Votum Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Germany Berlin-Chemie Ag Votum Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Germany Berlin-Chemie Ag Votum Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Germany Aliud Pharma Gmbh Olmesartan Al Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Germany Aliud Pharma Gmbh Olmesartan Al Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Germany Aliud Pharma Gmbh Olmesartan Al Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 79: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 79/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Germany Aliud Pharma Gmbh Olmesartan/Amlodipin Al Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Aliud Pharma Gmbh Olmesartan/Amlodipin Al Amlodipine 10mg Tablet, Olmesartan 40mg Tablet

Film-Coated Tablet Oral Use

Germany Aliud Pharma Gmbh Olmesartan/Amlodipin Al Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Aliud Pharma Gmbh Olmesartan/Hydrochlorothiazid Al

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Aliud Pharma Gmbh Olmesartan/Hydrochlorothiazid Al

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Aliud Pharma Gmbh Olmesartan/Hydrochlorothiazid Al

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Aliud Pharma Gmbh Olmesartan/Hydrochlorothiazid Al

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Abz-Pharma Gmbh Olmesartan Abz Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Germany Abz-Pharma Gmbh Olmesartan Abz Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Germany Abz-Pharma Gmbh Olmesartan Abz Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Germany Abz-Pharma Gmbh Olmesartan/Amlodipin Abz Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 80: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 80/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Germany Abz-Pharma Gmbh Olmesartan/Amlodipin Abz Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Germany Abz-Pharma Gmbh Olmesartan/Amlodipin Abz Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Ratiopharm Gmbh Olmedipin Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Ratiopharm Gmbh Olmedipin Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Germany Ratiopharm Gmbh Olmedipin Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Ratiopharm Gmbh Olmedipin Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Ratiopharm Gmbh Olmedipin Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Germany Ratiopharm Gmbh Olmedipin Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Ratiopharm Gmbh Olmesartan Abz Hydrochlorothiazide 12.5mg Tablet, Olmesartan 20mg Tablet

Film-Coated Tablet Oral Use

Germany Ratiopharm Gmbh Olmesartan Abz Hydrochlorothiazide 25mg Tablet, Olmesartan 20mg Tablet

Film-Coated Tablet Oral Use

Germany Ratiopharm Gmbh Olmesartan Abz Hydrochlorothiazide 12.5mg Tablet, Olmesartan 40mg Tablet

Film-Coated Tablet Oral Use

Page 81: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 81/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Germany Ratiopharm Gmbh Olmesartan Abz Hydrochlorothiazide 25mg Tablet, Olmesartan 40mg Tablet

Film-Coated Tablet Oral Use

Germany Ratiopharm Gmbh Olmesartan Ratiopharm Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Ratiopharm Gmbh Olmesartan Ratiopharm Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Ratiopharm Gmbh Olmesartan Ratiopharm Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Ratiopharm Gmbh Olmesartan Ratiopharm Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Ratiopharm Gmbh Olmesartan-Rtp Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Germany Ratiopharm Gmbh Olmesartan Ratiopharm Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Germany Ratiopharm Gmbh Olmesartan Ratiopharm Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Germany Tad Pharma Gmbh Olmeamlo Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Tad Pharma Gmbh Olmeamlo Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Germany Tad Pharma Gmbh Olmeamlo Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 82: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 82/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Germany Tad Pharma Gmbh Olmecor Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Germany Tad Pharma Gmbh Olmecor Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Germany Tad Pharma Gmbh Olmecor Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Germany Tad Pharma Gmbh Olmecor Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Tad Pharma Gmbh Olmecor Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Tad Pharma Gmbh Olmecor Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Tad Pharma Gmbh Olmecor Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Zentiva Pharma Gmbh

Olmesartan Amlodipin Zentiva

Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 6.95mg Tablet

Film-Coated Tablet Oral Use

Germany Zentiva Pharma Gmbh

Olmesartan Amlodipin Zentiva

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 13.89mg Tablet

Film-Coated Tablet Oral Use

Germany Zentiva Pharma Gmbh

Olmesartan Amlodipin Zentiva

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 6.95mg Tablet

Film-Coated Tablet Oral Use

Page 83: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 83/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Germany Hexal Ag Olmesartan Plus Amlodipin Hexal

Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 5mg Tablet

Film-Coated Tablet Oral Use

Germany Hexal Ag Olmesartan Hexal Plus Amlodipin

Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 5mg Tablet

Film-Coated Tablet Oral Use

Germany Hexal Ag Olmesartan Hexal Plus Amlodipin

Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 5mg Tablet

Film-Coated Tablet Oral Use

Germany Hexal Ag Olmesartan Hexal Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Germany Hexal Ag Olmesartan Hexal Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Germany Hexal Ag Olmesartan Hexal Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Germany Hexal Ag Olmesartan Hexal Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Hexal Ag Olmesartan Hexal Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Hexal Ag Olmesartan Hexal Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Hexal Ag Olmesartan Hexal Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 84: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 84/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Germany 1 A Pharma Gmbh Olmesartan/Amlodipin Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 5mg Tablet

Film-Coated Tablet Oral Use

Germany 1 A Pharma Gmbh Olmesartan/Amlodipin Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 10mg Tablet

Film-Coated Tablet Oral Use

Germany 1 A Pharma Gmbh Olmesartan/Amlodipin Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 5mg Tablet

Film-Coated Tablet Oral Use

Germany 1 A Pharma Gmbh Olmesartan 1 A Pharma Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Germany 1 A Pharma Gmbh Olmesartan 1 A Pharma Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Germany 1 A Pharma Gmbh Olmesartan 1 A Pharma Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Germany 1 A Pharma Gmbh Olmesartan Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany 1 A Pharma Gmbh Olmesartan Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany 1 A Pharma Gmbh Olmesartan Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany 1 A Pharma Gmbh Olmesartan Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 85: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 85/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Germany Betapharm Arzneimittel Gmbh

Olmesartanmedoxomil Amlodipin Beta

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Betapharm Arzneimittel Gmbh

Olmesartanmedoxomil Amlodipin Beta

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Germany Betapharm Arzneimittel Gmbh

Olmesartanmedoxomil Amlodipin Beta

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Glenmark Pharmaceuticals Europe Limited

Olmesartan Glenmark Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Germany Glenmark Pharmaceuticals Europe Limited

Olmesartan Glenmark Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Germany Glenmark Pharmaceuticals Europe Limited

Olmesartan Glenmark Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Germany Heumann Pharma Gmbh & Co. Generica Kg

Olmesartan Heumann Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Germany Heumann Pharma Gmbh & Co. Generica Kg

Olmesartan Heumann Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Germany Heumann Pharma Gmbh & Co. Generica Kg

Olmesartan Heumann Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Germany Heumann Pharma Gmbh & Co. Generica Kg

Olmesartan/Hydrochlorothiazid Heumann

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 86: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 86/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Germany Heumann Pharma Gmbh & Co. Generica Kg

Olmesartan/Hydrochlorothiazid Heumann

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Heumann Pharma Gmbh & Co. Generica Kg

Olmesartan/Hydrochlorothiazid Heumann

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Heumann Pharma Gmbh & Co. Generica Kg

Olmesartan/Hydrochlorothiazid Heumann

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Alembic Pharmaceuticals Europe Ltd

Olmesartanmedoxomil Alembic

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Germany Alembic Pharmaceuticals Europe Ltd

Olmesartanmedoxomil Alembic

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Germany Alembic Pharmaceuticals Europe Ltd

Olmesartanmedoxomil Alembic

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Germany Accord Healthcare Limited

Olmesartanmedoxomil/Amlodipin Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Accord Healthcare Limited

Olmesartanmedoxomil/Amlodipin Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Accord Healthcare Limited

Olmesartanmedoxomil/Amlodipin Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Germany Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 87: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 87/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Germany Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Germany Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Germany Hetero Europe S.L. Olmesartan Hetero Europe S.L.

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Germany Hetero Europe S.L. Olmesartan Hetero Europe S.L.

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Germany Hetero Europe S.L. Olmesartan Hetero Europe S.L.

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Germany Aurobindo Pharma Gmbh

Olmesartan/Hydrochlorothiazid Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Aurobindo Pharma Gmbh

Olmesartan/Hydrochlorothiazid Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Aurobindo Pharma Gmbh

Olmesartan/Hydrochlorothiazid Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Aurobindo Pharma Gmbh

Olmesartan/Hydrochlorothiazid Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Mylan Dura Gmbh Olmesartanmedoxomil Mylan

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Germany Mylan Dura Gmbh Olmesartanmedoxomil Mylan

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 88: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 88/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Germany Mylan Dura Gmbh Olmesartanmedoxomil/Amlodipin Mylan

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Mylan Dura Gmbh Olmesartanmedoxomil/Amlodipin Mylan

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Germany Mylan Dura Gmbh Olmesartanmedoxomil/Amlodipin Mylan

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Mylan Dura Gmbh Olmesartanmedoxomil Mylan

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Germany Macleods Pharma Uk Ltd

Olmesartan Medoxomillhydroehlorthiazid Macleods

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Macleods Pharma Uk Ltd

Olmesartan Medoxomil/Hydrochlorthiazid Macleods

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Macleods Pharma Uk Ltd

Olmesartan Medoxomil/Hydrochlorthiazid Macleods

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Macleods Pharma Uk Ltd

Olmesartan Medoxomillhydrochlorthiazid Macleods

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Macleods Pharma Uk Ltd

Olmesartan Medoxomil Macleods

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Germany Macleods Pharma Uk Ltd

Olmesartan Medoxomil Macleods

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Germany Macleods Pharma Uk Ltd

Olmesartan Medoxomil Macleods

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 89: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 89/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Germany Daiichi Sankyo Europe Gmbh

Olmesartan/Amlodipin Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmesartan/Amlodipin Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmesartan/Amlodipin Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmesartan/Amlodipin/Hct Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmesartan/Amlodipin/Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmesartan/Amlodipin/Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmesartan/Amlodipin/Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmesartan/Amlodipin/Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 90: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 90/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Germany Daiichi Sankyo Europe Gmbh

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Sevikar Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 91: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 91/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Germany Daiichi Sankyo Europe Gmbh

Olmesartan Hct Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmesartan Hct Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmesartan Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmesartan Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmes Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmes Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmesartan Daiichi Sankyo Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmesartan Daiichi Sankyo Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmesartan Daiichi Sankyo Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 92: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 92/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Germany Daiichi Sankyo Europe Gmbh

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmes Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmes Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmes Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmes Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmes Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Germany Daiichi Sankyo Europe Gmbh

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 93: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 93/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Germany Krka, D.D., Novo Mesto

Olmeamlo Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Greece Menarini International Operations Luxembourg S.A.

Orizal Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Greece Menarini International Operations Luxembourg S.A.

Orizal Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Greece Menarini International Operations Luxembourg S.A.

Orizal Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Greece Menarini International Operations Luxembourg S.A.

Orizal Plus Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Greece Menarini International Operations Luxembourg S.A.

Orizal Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Greece Menarini International Operations Luxembourg S.A.

Orizal Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 94: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 94/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Greece Menarini International Operations Luxembourg S.A.

Orizal Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Greece Menarini International Operations Luxembourg S.A.

Orizal Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Greece Menarini International Operations Luxembourg S.A.

Olartan-Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Greece Menarini International Operations Luxembourg S.A.

Olartan-Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Greece Menarini International Operations Luxembourg S.A.

Οlartan Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Greece Menarini International Operations Luxembourg S.A.

Οlartan Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Greece Menarini International Operations Luxembourg S.A.

Οlartan Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 95: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 95/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Greece Mylan S.A.S Olmesartan Mylan Olmesartan 10mg Tablet Film-Coated Tablet Oral Use

Greece Mylan S.A.S Olmesartan Mylan Olmesartan 20mg Tablet Film-Coated Tablet Oral Use

Greece Mylan S.A.S Olmesartan Mylan Olmesartan 30mg Tablet Film-Coated Tablet Oral Use

Greece Pharmaserve-Lilly Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Greece Pharmaserve-Lilly Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Greece Pharmaserve-Lilly Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Greece Pharmaserve-Lilly Olmetec Plus® Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Greece Pharmaserve-Lilly Olmetec Plus® Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Greece Pharmaserve-Lilly Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Greece Pharmaserve-Lilly Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 96: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 96/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Greece Pfizer Hellas, A.E. Sevikar Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Greece Pfizer Hellas, A.E. Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Greece Pfizer Hellas, A.E. Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Greece Pfizer Hellas, A.E. Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Greece Pfizer Hellas, A.E. Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Greece Pfizer Hellas, A.E. Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Greece Pfizer Hellas, A.E. Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Greece Pfizer Hellas, A.E. Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 97: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 97/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Greece Sanofi-Aventis Aebe Olmesartan+hydrochlorothiazide Zentiva

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Greece Sanofi-Aventis Aebe Olmesartan+hydrochlorothiazide Zentiva

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Greece Sanofi-Aventis Aebe Olmesartan+hydrochlorothiazide Zentiva

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Greece Sanofi-Aventis Aebe Olmesartan+hydrochlorothiazide Zentiva

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Greece Sanofi-Aventis Aebe Olmesartan Zentiva Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Greece Sanofi-Aventis Aebe Olmesartan Zentiva Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Greece Sanofi-Aventis Aebe Olmesartan Zentiva Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Greece Sanofi-Aventis Aebe Olmesartan Zentiva Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Greece Norma Hellas S.A. Co-Ipertas Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral

Greece Norma Hellas S.A. Co-Ipertas Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral

Page 98: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 98/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Greece Norma Hellas S.A. Co-Ipertas Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral

Greece Norma Hellas S.A. Co-Ipertas Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral

Greece Norma Hellas S.A. Ipertas Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral

Greece Norma Hellas S.A. Ipertas Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral

Greece Norma Hellas S.A. Ipertas Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral

Greece Generics Pharma Hellas Ltd

Olmesartan + Hctz Mylan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Greece Generics Pharma Hellas Ltd

Olmesartan + Hctz Mylan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Greece Generics Pharma Hellas Ltd

Olmesartan + Hctz Mylan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Greece Generics Pharma Hellas Ltd

Olmesartan + Hctz Mylan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Greece Teva Pharma B.V. Olmesartan Medoxomil Teva Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 99: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 99/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Greece Teva Pharma B.V. Olmesartan Medoxomil Teva Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Greece Teva Pharma B.V. Olmesartan Medoxomil Teva Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Greece Sandoz Pharmaceuticals D.D.

Olmesartan + Amlodipine Sandoz

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Greece Sandoz Pharmaceuticals D.D.

Olmesartan + Amlodipine Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Greece Sandoz Pharmaceuticals D.D.

Olmesartan + Amlodipine Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Greece Sandoz Pharmaceuticals D.D.

Olmesartan+hctz Sandoz Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Greece Sandoz Pharmaceuticals D.D.

Olmesartan+hctz Sandoz Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Greece Sandoz Pharmaceuticals D.D.

Olmesartan+hctz Sandoz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Greece Sandoz Pharmaceuticals D.D.

Olmesartan+hctz Sandoz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Greece Sandoz Pharmaceuticals D.D.

Olmesartan Sandoz Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Greece Sandoz Pharmaceuticals D.D.

Olmesartan Sandoz Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 100: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 100/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Greece Sandoz Pharmaceuticals D.D.

Olmesartan Sandoz Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Hungary Menarini International Operations Luxembourg S.A.

Duactan Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Hungary Menarini International Operations Luxembourg S.A.

Duactan Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Hungary Menarini International Operations Luxembourg S.A.

Duactan Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Hungary Menarini International Operations Luxembourg S.A.

Duactan Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Hungary Menarini International Operations Luxembourg S.A.

Duactan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Hungary Menarini International Operations Luxembourg S.A.

Duactan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 101: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 101/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Hungary Menarini International Operations Luxembourg S.A.

Duactan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Hungary Menarini International Operations Luxembourg S.A.

Duactan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Hungary Menarini International Operations Luxembourg S.A.

Laresin Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Hungary Menarini International Operations Luxembourg S.A.

Laresin Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Hungary Menarini International Operations Luxembourg S.A.

Laresin Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Hungary Berlin-Chemie Ag Laresin Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Hungary Berlin-Chemie Ag Laresin Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 102: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 102/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Hungary Berlin-Chemie Ag Laresin Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Hungary Berlin-Chemie Ag Laresin Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Hungary Teva Gyógyszergyár Zrt

Olmesartan Medoxomil Teva Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Hungary Teva Gyógyszergyár Zrt

Olmesartan Medoxomil Teva Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Hungary Teva Gyógyszergyár Zrt

Olmesartan Medoxomil Teva Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Hungary Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Hungary Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Hungary Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Hungary Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Hungary Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 103: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 103/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Hungary Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Hungary Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Hungary Krka, D.D., Novo Mesto

Olmiza Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Hungary Krka, D.D., Novo Mesto

Olmiza Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Hungary Krka, D.D., Novo Mesto

Olmiza Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Iceland Menarini International Operations Luxembourg S.A.

Alea Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Iceland Menarini International Operations Luxembourg S.A.

Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Iceland Menarini International Operations Luxembourg S.A.

Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Iceland Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 104: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 104/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Iceland Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Iceland Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Iceland Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Iceland Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Iceland Menarini International Operations Luxembourg S.A.

Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Iceland Menarini International Operations Luxembourg S.A.

Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Iceland Menarini International Operations Luxembourg S.A.

Benetor Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 105: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 105/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Iceland Menarini International Operations Luxembourg S.A.

Benetor Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Iceland Menarini International Operations Luxembourg S.A.

Benetor Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Iceland Menarini International Operations Luxembourg S.A.

Benetor Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Iceland Menarini International Operations Luxembourg S.A.

Benetor Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Iceland Daiichi Sankyo Europe Gmbh

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Iceland Daiichi Sankyo Europe Gmbh

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Iceland Daiichi Sankyo Europe Gmbh

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Iceland Daiichi Sankyo Europe Gmbh

Sevikar Comp Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 106: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 106/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Iceland Daiichi Sankyo Europe Gmbh

Sevikar Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Iceland Daiichi Sankyo Europe Gmbh

Sevikar Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Iceland Daiichi Sankyo Europe Gmbh

Sevikar Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Iceland Daiichi Sankyo Europe Gmbh

Sevikar Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Iceland Daiichi Sankyo Europe Gmbh

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Iceland Daiichi Sankyo Europe Gmbh

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Iceland Daiichi Sankyo Europe Gmbh

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 107: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 107/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Iceland Daiichi Sankyo Europe Gmbh

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Iceland Daiichi Sankyo Europe Gmbh

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Iceland Daiichi Sankyo Europe Gmbh

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Iceland Daiichi Sankyo Europe Gmbh

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Ireland Menarini International Operations Luxembourg S.A.

Konverge Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Ireland Menarini International Operations Luxembourg S.A.

Konverge Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Ireland Menarini International Operations Luxembourg S.A.

Konverge Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Ireland Menarini International Operations Luxembourg S.A.

Konverge Plus Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 108: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 108/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Ireland Menarini International Operations Luxembourg S.A.

Konverge Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Ireland Menarini International Operations Luxembourg S.A.

Konverge Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Ireland Menarini International Operations Luxembourg S.A.

Konverge Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Ireland Menarini International Operations Luxembourg S.A.

Konverge Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Ireland Menarini International Operations Luxembourg S.A.

Omesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Ireland Menarini International Operations Luxembourg S.A.

Omesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Ireland Menarini International Operations Luxembourg S.A.

Omesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 109: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 109/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Ireland Menarini International Operations Luxembourg S.A.

Omesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Ireland Menarini International Operations Luxembourg S.A.

Omesar Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Ireland Menarini International Operations Luxembourg S.A.

Omesar Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Ireland Menarini International Operations Luxembourg S.A.

Omesar Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Ireland Teva Pharma B.V. Olmesartan Medoxomil Teva Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Ireland Teva Pharma B.V. Olmesartan Medoxomil Teva Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Ireland Glenmark Pharmaceuticals Europe Limited

Olmesartan Medoxomil Glenmark

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Ireland Glenmark Pharmaceuticals Europe Limited

Olmesartan Medoxomil Glenmark

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 110: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 110/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Ireland Glenmark Pharmaceuticals Europe Limited

Olmesartan Medoxomil Glenmark

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Ireland Rowex Ltd Olmesartan Hydrochlorothiazide Rowex

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Ireland Rowex Ltd Olmesartan Hydrochlorothiazide Rowex

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Ireland Rowex Ltd Olmesartan Hydrochlorothiazide Rowex

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Ireland Rowex Ltd Olmesartan Hydrochlorothiazide Rowex

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Ireland Rowex Ltd Olmesartan Rowex Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Ireland Rowex Ltd Olmesartan Rowex Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Ireland Rowex Ltd Olmesartan Rowex Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Ireland Actavis Group Ptc Ehf.

Olmesartan Hydrochlorothiaizde Actavis

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Ireland Actavis Group Ptc Ehf.

Olmesartan Hydrochlorothiazide Actavis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 111: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 111/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Ireland Actavis Group Ptc Ehf.

Olmesartan Hydrochlorothiazide Actavis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Ireland Actavis Group Ptc Ehf.

Olmesartan Hydrochlorothiazide Actavis

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Ireland Actavis Group Ptc Ehf.

Olmesartan Actavis Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Ireland Actavis Group Ptc Ehf.

Olmesartan Actavis Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Ireland Actavis Group Ptc Ehf.

Olmesartan Actavis Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Ireland Actavis Group Ptc Ehf.

Olmesartan Actavis Olmesartan Medoxomil 5mg Tablet

Film-Coated Tablet Oral Use

Ireland Daiichi Sankyo Ireland Limited

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Ireland Daiichi Sankyo Ireland Limited

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Ireland Daiichi Sankyo Ireland Limited

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Ireland Daiichi Sankyo Ireland Limited

Sevikar Plus Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 112: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 112/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Ireland Daiichi Sankyo Ireland Limited

Sevikar Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Ireland Daiichi Sankyo Ireland Limited

Sevikar Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Ireland Daiichi Sankyo Ireland Limited

Sevikar Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Ireland Daiichi Sankyo Ireland Limited

Sevikar Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Ireland Daiichi Sankyo Ireland Limited

Benetor Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Ireland Daiichi Sankyo Ireland Limited

Benetor Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Ireland Daiichi Sankyo Ireland Limited

Benetor Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 113: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 113/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Ireland Daiichi Sankyo Ireland Limited

Benetor Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Ireland Daiichi Sankyo Ireland Limited

Benetor Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Ireland Daiichi Sankyo Ireland Limited

Benetor Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Ireland Daiichi Sankyo Ireland Limited

Benetor Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Ireland Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochlorothiazide Accord Healthcare

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Ireland Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochlorothiazide Accord Healthcare

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Ireland Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochlorothiazide Accord Healthcare

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Ireland Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochlorothiazide Accord Healthcare

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Ireland Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord Healthcare

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Ireland Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord Healthcare

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 114: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 114/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Ireland Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord Healthcare

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Ireland Accord Healthcare Limited

Olmesartan Medoxomil Accord Healthcare

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Ireland Accord Healthcare Limited

Olmesartan Medoxomil Accord Healthcare

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Ireland Accord Healthcare Limited

Olmesartan Medoxomil Accord Healthcare

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Ireland Stada Arzneimittel Ag

Olmesartan/Hydrochlorothiazide Stada Arzneimittel Ag

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Ireland Stada Arzneimittel Ag

Olmesartan/Hydrochlorothiazide Stada Arzneimittel Ag

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Ireland Stada Arzneimittel Ag

Olmesartan/Hydrochlorothiazide Film-Coated Tablets

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Ireland Stada Arzneimittel Ag

Olmesartan/Hydrochlorothiazide Stada Arzneimittel Ag

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Ireland Generics [uk] Limited Olmesartan Medoxomil Generics [uk]

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Ireland Generics [uk] Limited Olmesartan Medoxomil Generics [uk]

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Ireland Generics [uk] Limited Olmesartan Medoxomil Generics [uk]

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 115: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 115/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Ireland Teva Pharma B.V. Olmesartan Medoxomil Teva Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Ireland Mcdermott Laboratories Ltd

Olmesartan /Amlodipine Mylan

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Ireland Mcdermott Laboratories Ltd

Olmesartan /Amlodipine Mylan

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Ireland Mcdermott Laboratories Ltd

Olmesartan /Amlodipine Mylan

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Ireland Clonmel Healthcare Ltd.

Olmesartan Medoxomil Clonmel

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Ireland Clonmel Healthcare Ltd.

Olmesartan Medoxomil Clonmel

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Ireland Clonmel Healthcare Ltd.

Olmesartan Medoxomil Clonmel

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Ireland Clonmel Healthcare Ltd.

Olmesartan/Amlodipine Clonmel

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Ireland Clonmel Healthcare Ltd.

Olmesartan/Amlodipine Clonmel

Amlodipine 10mg Tablet, Olmesartan 40mg Tablet

Film-Coated Tablet Oral Use

Ireland Clonmel Healthcare Ltd.

Olmesartan/Amlodipine Clonmel

Amlodipine 5mg Tablet, Olmesartan 40mg Tablet

Film-Coated Tablet Oral Use

Ireland Clonmel Healthcare Ltd.

Olmesartan/Hydrochlorothiazide Clonmel

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Ireland Clonmel Healthcare Ltd.

Olmesartan/Hydrochlorothiazide Clonmel

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 116: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 116/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Ireland Clonmel Healthcare Ltd.

Olmesartan/Hydrochlorothiazide Clonmel

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Ireland Clonmel Healthcare Ltd.

Olmesartan/Hydrochlorothiazide Clonmel

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Ireland Krka, D.D., Novo Mesto

Olmesartan/Amlodipine Krka Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Ireland Krka, D.D., Novo Mesto

Olmesartan/Amlodipine Krka Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Ireland Krka, D.D., Novo Mesto

Olmesartan/Amlodipine Krka Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Ireland Krka, D.D., Novo Mesto

Olmesartan/Hydrochlorothiazide Krka

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Ireland Krka, D.D., Novo Mesto

Olmesartan/Hydrochlorothiazide Krka

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Ireland Krka, D.D., Novo Mesto

Olmesartan/Hydrochlorothiazide Krka

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Ireland Krka, D.D., Novo Mesto

Olmesartan/Hydrochlorothiazide Krka

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Ireland Krka, D.D., Novo Mesto

Olmesartan Krka Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 117: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 117/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Ireland Krka, D.D., Novo Mesto

Olmesartan Krka Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Ireland Krka, D.D., Novo Mesto

Olmesartan Krka Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Menarini International Operations Luxembourg S.A.

Bivis Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Menarini International Operations Luxembourg S.A.

Bivis Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Italy Menarini International Operations Luxembourg S.A.

Bivis Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Menarini International Operations Luxembourg S.A.

Giant Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Menarini International Operations Luxembourg S.A.

Giant Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 118: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 118/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Menarini International Operations Luxembourg S.A.

Giant Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Menarini International Operations Luxembourg S.A.

Olprezide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Menarini International Operations Luxembourg S.A.

Olprezide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Menarini International Operations Luxembourg S.A.

Plaunazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Menarini International Operations Luxembourg S.A.

Plaunazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Menarini International Operations Luxembourg S.A.

Olpress Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Menarini International Operations Luxembourg S.A.

Olpress Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 119: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 119/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Menarini International Operations Luxembourg S.A.

Olpress Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Menarini International Operations Luxembourg S.A.

Olprezide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Menarini International Operations Luxembourg S.A.

Olprezide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Menarini International Operations Luxembourg S.A.

Plaunac Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Menarini International Operations Luxembourg S.A.

Plaunac Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Menarini International Operations Luxembourg S.A.

Plaunac Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Menarini International Operations Luxembourg S.A.

Plaunazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 120: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 120/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Menarini International Operations Luxembourg S.A.

Plaunazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Substipharm Developpement

Pieralzan Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Substipharm Developpement

Pieralzan Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Substipharm Developpement

Pieralzan Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Zentiva Italia Srl Olmesartan E Idroclorotiazide Zentiva

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Zentiva Italia Srl Olmesartan E Idroclorotiazide Zentiva

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Zentiva Italia Srl Olmesartan E Idroclorotiazide Zentiva

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Zentiva Italia Srl Olmesartan E Idroclorotiazide Zentiva

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Zentiva Italia Srl Olmesartan Medoxomil E Amlodipina Zentiva

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Zentiva Italia Srl Olmesartan Medoxomil E Amlodipina Zentiva

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 121: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 121/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Zentiva Italia Srl Olmesartan Medoxomil E Amlodipina Zentiva

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Zentiva Italia Srl Olmesartan Medoxomil Zentiva

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Zentiva Italia Srl Olmesartan Medoxomil Zentiva

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Zentiva Italia Srl Olmesartan Medoxomil Zentiva

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Vi.Rel Pharma Sas Olmesartan Vi.Rel Pharma Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Vi.Rel Pharma Sas Olmesartan Vi.Rel Pharma Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Hcs Bvba Olmesartan Hcs Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Hcs Bvba Olmesartan Hcs Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Hcs Bvba Olmesartan Hcs Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Hcs Bvba Olmesartan Medoxomil E Idroclorotiazide Hcs

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Hcs Bvba Olmesartan Medoxomil E Idroclorotiazide Hcs

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Hcs Bvba Olmesartan Medoxomil E Idroclorotiazide Hcs

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 122: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 122/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Hcs Bvba Olmesartan Medoxomil E Idroclorotiazide Hcs

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Hcs Bvba Olmesartan Hcs Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Hcs Bvba Olmesartan Hcs Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Hcs Bvba Olmesartan Hcs Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Sandoz S.P.A. Olmesartan Medoxomil E Amlodipina Sandoz

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Sandoz S.P.A. Olmesartan Medoxomil E Amlodipina Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Italy Sandoz S.P.A. Olmesartan Medoxomil E Amlodipina Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Sandoz S.P.A. Olmesartan Medoxomil Sandoz

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Sandoz S.P.A. Olmesartan Medoxomil Sandoz

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Sandoz S.P.A. Olmesartan Medoxomil Sandoz

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Sandoz S.P.A. Olmesartan E Idroclorotiazide Sandoz

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Sandoz S.P.A. Olmesartan E Idroclorotiazide Sandoz

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 123: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 123/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Sandoz S.P.A. Olmesartan E Idroclorotiazide Sandoz

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Sandoz S.P.A. Olmesartan E Idroclorotiazide Sandoz

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Teva Italia S.R.L. Olmesartan Medoxomil E Idroclorotiazide Teva

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Teva Italia S.R.L. Olmesartan Medoxomil E Idroclorotiazide Teva

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Teva Italia S.R.L. Olmesartan Medoxomil E Idroclorotiazide Teva

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Teva Italia S.R.L. Olmesartan Medoxomil E Idroclorotiazide Teva

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Teva Italia S.R.L. Olmesartan Medoxomil Teva Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Teva Italia S.R.L. Olmesartan Medoxomil Teva Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Teva Italia S.R.L. Olmesartan Medoxomil Teva Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 124: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 124/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Idroclorotiazide Accord

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Idroclorotiazide Accord

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Idroclorotiazide Accord

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Idroclorotiazide Accord

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Idroclorotiazide Accord

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Idroclorotiazide Accord

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Idroclorotiazide Accord

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Idroclorotiazide Accord

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 125: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 125/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Idroclorotiazide Accord

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Idroclorotiazide Accord

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Idroclorotiazide Accord

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Idroclorotiazide Accord

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Idroclorotiazide Accord

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Idroclorotiazide Accord

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Idroclorotiazide Accord

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Idroclorotiazide Accord

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 126: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 126/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 127: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 127/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil E Amlodipina Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 128: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 128/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Teva B.V Olmesartan Medoxomil E Amlodipina Teva

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Teva B.V Olmesartan Medoxomil E Amlodipina Teva

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Italy Teva B.V Olmesartan Medoxomil E Amlodipina Teva

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Laboratorio Farmaceutico Ct Srl

Olmedie Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Laboratorio Farmaceutico Ct Srl

Olmedie Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Laboratorio Farmaceutico Ct Srl

Olmedie Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Laboratorio Farmaceutico Ct Srl

Presdiur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Laboratorio Farmaceutico Ct Srl

Presdiur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 129: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 129/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Laboratorio Farmaceutico Ct Srl

Presdiur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Laboratorio Farmaceutico Ct Srl

Presdiur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 130: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 130/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 131: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 131/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 132: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 132/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Laboratori Alter S.R.L.

Olmesartan Medoxomil E Idroclorotiazide Alter

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Laboratori Alter S.R.L.

Olmesartan Medoxomil E Idroclorotiazide Alter

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Laboratori Alter S.R.L.

Olmesartan Medoxomil E Idroclorotiazide Alter

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 133: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 133/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Laboratori Alter S.R.L.

Olmesartan Medoxomil E Idroclorotiazide Alter

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Laboratori Alter S.R.L.

Olmesartan Medoxomil Alter Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Laboratori Alter S.R.L.

Olmesartan Medoxomil Alter Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Laboratori Alter S.R.L.

Olmesartan Medoxomil Alter Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Tecnigen S.R.L. Olmesartan E Idroclorotiazide Tecnigen

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Tecnigen S.R.L. Olmesartan E Idroclorotiazide Tecnigen

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Tecnigen S.R.L. Olmesartan E Idroclorotiazide Tecnigen

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Tecnigen S.R.L. Olmesartan E Idroclorotiazide Tecnigen

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Tecnigen S.R.L. Olmesartan Tecnigen Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Tecnigen S.R.L. Olmesartan Tecnigen Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Tecnigen S.R.L. Olmesartan Tecnigen Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 134: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 134/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Pensa Pharma S.P.A. Olmesartan Medoxomil Pensa

Olmesartan Medoxomil 10mg Tablet

Film Coated Tablet Oral Use

Italy Pensa Pharma S.P.A. Olmesartan Medoxomil Pensa

Olmesartan Medoxomil 20mg Tablet

Film Coated Tablet Oral Use

Italy Pensa Pharma S.P.A. Olmesartan Medoxomil Pensa

Olmesartan Medoxomil 40mg Tablet

Film Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 135: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 135/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 136: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 136/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil Daiichi Sankyo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 137: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 137/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil Daiichi Sankyo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil Daiichi Sankyo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil Daiichi Sankyo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil Daiichi Sankyo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 138: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 138/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 139: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 139/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 140: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 140/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 141: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 141/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 142: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 142/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 143: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 143/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 144: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 144/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 145: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 145/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 146: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 146/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 147: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 147/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan E Amlodipina Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan E Amlodipina Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan E Amlodipina Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan E Amlodipina Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan E Amlodipina Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmesartan E Amlodipina Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 148: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 148/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 149: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 149/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 150: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 150/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 151: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 151/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Daiichi Sankyo Italia S.P.A

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Daiichi Sankyo Italia S.P.A

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Eg S.P.A. Olmesartan E Idroclorotiazide Eg

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Eg S.P.A. Olmesartan E Idroclorotiazide Eg

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Eg S.P.A. Olmesartan E Idroclorotiazide Eg

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Eg S.P.A. Olmesartan E Idroclorotiazide Eg

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Eg S.P.A. Olmesartan Medoxomil Eg Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Eg S.P.A. Olmesartan Medoxomil Eg Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 152: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 152/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Eg S.P.A. Olmesartan Medoxomil Eg Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Eg S.P.A. Olmesartan Medoxomil Eg Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan Medoxomil Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan Medoxomil Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan Medoxomil Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan Medoxomil Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan Medoxomil Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan Medoxomil Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan Medoxomil Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan Medoxomil Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan Medoxomil Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 153: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 153/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 154: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 154/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 155: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 155/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 156: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 156/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 157: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 157/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Aurobindo Pharma (Italia) S.R.L.

Olmesartan E Idroclorotiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 158: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 158/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Doc Generici S.R.L. Olmesartan Doc Generici Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Doc Generici S.R.L. Olmesartan Doc Generici Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Doc Generici S.R.L. Olmesartan Doc Generici Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Doc Generici S.R.L. Olmesartan E Amlodipina Doc

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Doc Generici S.R.L. Olmesartan E Amlodipina Doc

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Doc Generici S.R.L. Olmesartan E Amlodipina Doc

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Doc Generici S.R.L. Olmesartan E Amlodipina Doc

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Doc Generici S.R.L. Olmesartan E Amlodipina Doc

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Italy Doc Generici S.R.L. Olmesartan E Amlodipina Doc

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Italy Doc Generici S.R.L. Olmesartan E Idroclorotiazide Doc

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Doc Generici S.R.L. Olmesartan E Idroclorotiazide Doc

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Doc Generici S.R.L. Olmesartan E Idroclorotiazide Doc

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 159: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 159/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Doc Generici S.R.L. Olmesartan E Idroclorotiazide Doc

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Doc Generici S.R.L. Olmesartan E Idroclorotiazide Doc

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Doc Generici S.R.L. Olmesartan E Idroclorotiazide Doc

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Italy Doc Generici S.R.L. Olmesartan E Idroclorotiazide Doc

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Mylan S.P.A. Olmesartan E Idroclorotiazide Mylan

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 13mg Tablet

Film-Coated Tablet Oral Use

Italy Mylan S.P.A. Olmesartan E Idroclorotiazide Mylan

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 13mg Tablet

Film-Coated Tablet Oral Use

Italy Mylan S.P.A. Olmesartan Medoxomil E Idroclorotiazide Mylan

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 13mg Tablet

Film-Coated Tablet Oral Use

Italy Mylan S.P.A. Olmesartan Medoxomil E Idroclorotiazide Mylan

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Italy Mylan S.P.A. Olmesartan Medoxomil Mylan

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 160: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 160/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Italy Mylan S.P.A. Olmesartan Medoxomil Mylan

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Italy Mylan S.P.A. Olmesartan Medoxomil Mylan

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Italy Mylan S.P.A. Olmesartan Medoxomil Mylan

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Italy Krka, D.D., Novo Mesto

Olmesartan E Amlodipina Krka

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Italy Krka, D.D., Novo Mesto

Olmesartan E Amlodipina Krka

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Italy Krka, D.D., Novo Mesto

Olmesartan E Amlodipina Krka

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Latvia Menarini International Operations Luxembourg S.A.

Mesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Latvia Menarini International Operations Luxembourg S.A.

Mesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Latvia Menarini International Operations Luxembourg S.A.

Sanoral Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 161: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 161/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Latvia Menarini International Operations Luxembourg S.A.

Sanoral Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Latvia Menarini International Operations Luxembourg S.A.

Sanoral Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Latvia Menarini International Operations Luxembourg S.A.

Sanoral Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Latvia Menarini International Operations Luxembourg S.A.

Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Latvia Menarini International Operations Luxembourg S.A.

Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Latvia Menarini International Operations Luxembourg S.A.

Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Latvia Menarini International Operations Luxembourg S.A.

Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 162: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 162/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Latvia Menarini International Operations Luxembourg S.A.

Mesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Latvia Menarini International Operations Luxembourg S.A.

Mesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Latvia Menarini International Operations Luxembourg S.A.

Mesar Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Latvia Menarini International Operations Luxembourg S.A.

Mesar Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Latvia Menarini International Operations Luxembourg S.A.

Mesar Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Latvia Hcs Bvba Olssa Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Latvia Hcs Bvba Olssa Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Latvia Hcs Bvba Olssa Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 163: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 163/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Latvia Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Latvia Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Latvia Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Latvia Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Latvia Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Latvia Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Latvia Teva B.V Olmesartan Medoxomil/Amlodipine Teva

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Latvia Teva B.V Olmesartan Medoxomil/Amlodipine Teva

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Latvia Teva B.V Olmesartan Medoxomil/Amlodipine Teva

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Latvia Zentiva, K.S. Osaver Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Latvia Zentiva, K.S. Osaver Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 164: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 164/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Latvia Zentiva, K.S. Osaver Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Latvia Zentiva, K.S. Osaver Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Latvia Zentiva, K.S. Olmesartan Medoxomil/Amlodipine Zentiva

Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 6.95mg Tablet

Film-Coated Tablet Oral Use

Latvia Zentiva, K.S. Olmesartan Medoxomil/Amlodipine Zentiva

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 13.89mg Tablet

Film-Coated Tablet Oral Use

Latvia Zentiva, K.S. Olmesartan Medoxomil/Amlodipine Zentiva

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 6.95mg Tablet

Film-Coated Tablet Oral Use

Latvia Sandoz Pharmaceuticals D.D.

Olmesartan Medoxomil/Amlodipine Sandoz

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Latvia Sandoz Pharmaceuticals D.D.

Olmesartan Medoxomil/Amlodipine Sandoz

Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 5mg Tablet

Film-Coated Tablet Oral Use

Latvia Sandoz Pharmaceuticals D.D.

Olmesartan Medoxomil/Amlodipine Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Latvia Sandoz Pharmaceuticals D.D.

Olmesartan Medoxomil/Amlodipine Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 165: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 165/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Latvia Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12500μg Tablet

Film-Coated Tablet Oral Use

Latvia Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Latvia Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12500μg Tablet

Film-Coated Tablet Oral Use

Latvia Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Latvia Krka, D.D., Novo Mesto

Olmesartan Krka Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Latvia Krka, D.D., Novo Mesto

Olmesartan Krka Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Latvia Krka, D.D., Novo Mesto

Olmesartan Krka Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Latvia Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Latvia Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Latvia Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 166: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 166/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Menarini International Operations Luxembourg S.A.

Mesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Menarini International Operations Luxembourg S.A.

Mesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Menarini International Operations Luxembourg S.A.

Sanoral Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Menarini International Operations Luxembourg S.A.

Sanoral Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Menarini International Operations Luxembourg S.A.

Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Menarini International Operations Luxembourg S.A.

Sanoral Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Menarini International Operations Luxembourg S.A.

Sanoral Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 167: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 167/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Menarini International Operations Luxembourg S.A.

Sanoral Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Menarini International Operations Luxembourg S.A.

Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Menarini International Operations Luxembourg S.A.

Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Menarini International Operations Luxembourg S.A.

Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Menarini International Operations Luxembourg S.A.

Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Menarini International Operations Luxembourg S.A.

Mesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Menarini International Operations Luxembourg S.A.

Mesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 168: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 168/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Menarini International Operations Luxembourg S.A.

Mesar Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Menarini International Operations Luxembourg S.A.

Mesar Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Lithuania Menarini International Operations Luxembourg S.A.

Mesar Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil Actavis

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil Actavis

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil Actavis

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil Actavis

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil Actavis

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil Actavis

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 169: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 169/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil Actavis

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil Actavis

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil Actavis

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil Actavis

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil Actavis

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil Actavis

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil Actavis

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil Actavis

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 170: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 170/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 171: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 171/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 172: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 172/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Actavis Group Ptc Ehf.

Olmesartan Medoxomil/Hydrochlorothiazide Actavis

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 173: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 173/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 174: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 174/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 175: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 175/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 176: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 176/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 177: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 177/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Lithuania Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Lithuania Teva B.V Olmesartan Medoxomil/Amlodipine Teva

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Teva B.V Olmesartan Medoxomil/Amlodipine Teva

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Teva B.V Olmesartan Medoxomil/Amlodipine Teva

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zentiva, K.S. Osaver Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 178: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 178/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Zentiva, K.S. Osaver Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zentiva, K.S. Osaver Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zentiva, K.S. Osaver Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 179: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 179/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 180: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 180/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 181: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 181/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 182: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 182/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 183: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 183/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 184: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 184/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Sandoz Pharmaceuticals D.D.

Olmesartan Medoxomil /Amlodipine Sandoz

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Sandoz Pharmaceuticals D.D.

Olmesartan Medoxomil /Amlodipine Sandoz Pharmaceuticals D.D.

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 185: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 185/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Sandoz Pharmaceuticals D.D.

Olmesartan Medoxomil /Amlodipine Sandoz Pharmaceuticals D.D.

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Sandoz Pharmaceuticals D.D.

Olmesartan Medoxomil /Amlodipine Sandoz Pharmaceuticals D.D.

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Lithuania Krka, D.D., Novo Mesto

Olmira Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Krka, D.D., Novo Mesto

Olmira Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Lithuania Krka, D.D., Novo Mesto

Olmira Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Lithuania Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 186: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 186/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Lithuania Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Lithuania Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Menarini International Operations Luxembourg S.A.

Belsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Menarini International Operations Luxembourg S.A.

Belsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Menarini International Operations Luxembourg S.A.

Forzaten Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Menarini International Operations Luxembourg S.A.

Forzaten Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Menarini International Operations Luxembourg S.A.

Forzaten Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 187: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 187/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Luxembourg Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Menarini International Operations Luxembourg S.A.

Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Menarini International Operations Luxembourg S.A.

Belsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Menarini International Operations Luxembourg S.A.

Belsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 188: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 188/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Luxembourg Menarini International Operations Luxembourg S.A.

Belsar Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Menarini International Operations Luxembourg S.A.

Belsar Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Menarini International Operations Luxembourg S.A.

Belsar Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Ratiopharm Gmbh Olmesartan Comp Ratiopharm

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Ratiopharm Gmbh Olmesartan Comp Ratiopharm

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Ratiopharm Gmbh Olmesartan Comp Ratiopharm

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Ratiopharm Gmbh Olmesartan Comp Ratiopharm

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Ratiopharm Gmbh Olmesartan Ratiopharm Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 189: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 189/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Luxembourg Ratiopharm Gmbh Olmesartan Ratiopharm Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Ratiopharm Gmbh Olmesartan Ratiopharm Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Eurogenerics N.V./S.A.

Olmesartan Eg Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Eurogenerics N.V./S.A.

Olmesartan Eg Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Eurogenerics N.V./S.A.

Olmesartan Eg Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Eurogenerics N.V./S.A.

Olmesartan Plus Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Eurogenerics N.V./S.A.

Olmesartan Plus Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Eurogenerics N.V./S.A.

Olmesartan Plus Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Eurogenerics N.V./S.A.

Olmesartan Plus Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Eurogenerics N.V./S.A.

Olmesartan/Amlodipine Eg Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Eurogenerics N.V./S.A.

Olmesartan/Amlodipine Eg Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 190: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 190/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Luxembourg Eurogenerics N.V./S.A.

Olmesartan/Amlodipine Eg Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Daiichi Sankyo Belgium S.A

Sevikar/Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Daiichi Sankyo Belgium S.A

Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Daiichi Sankyo Belgium S.A

Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Daiichi Sankyo Belgium S.A

Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Daiichi Sankyo Belgium S.A

Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Daiichi Sankyo Belgium S.A

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Daiichi Sankyo Belgium S.A

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 191: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 191/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Luxembourg Daiichi Sankyo Belgium S.A

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Daiichi Sankyo Belgium S.A

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Daiichi Sankyo Belgium S.A

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Daiichi Sankyo Belgium S.A

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Daiichi Sankyo Belgium S.A

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Daiichi Sankyo Belgium S.A

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Daiichi Sankyo Belgium S.A

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Luxembourg Daiichi Sankyo Belgium S.A

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Malta Menarini International Operations Luxembourg S.A.

Konverge Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 192: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 192/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Malta Menarini International Operations Luxembourg S.A.

Konverge Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Malta Menarini International Operations Luxembourg S.A.

Konverge Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Malta Menarini International Operations Luxembourg S.A.

Konverge Plus Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Malta Menarini International Operations Luxembourg S.A.

Konverge Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Malta Menarini International Operations Luxembourg S.A.

Konverge Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Malta Menarini International Operations Luxembourg S.A.

Konverge Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Malta Menarini International Operations Luxembourg S.A.

Konverge Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 193: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 193/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Malta Menarini International Operations Luxembourg S.A.

Omesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Malta Menarini International Operations Luxembourg S.A.

Omesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Malta Menarini International Operations Luxembourg S.A.

Omesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Malta Menarini International Operations Luxembourg S.A.

Omesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Malta Menarini International Operations Luxembourg S.A.

Omesar Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Malta Menarini International Operations Luxembourg S.A.

Omesar Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Malta Menarini International Operations Luxembourg S.A.

Omesar Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 194: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 194/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Malta Actavis Group Ptc Ehf.

Vivactra Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Malta Actavis Group Ptc Ehf.

Vivactra Olmesartan Medoxomil 5mg Tablet

Film-Coated Tablet Oral Use

Malta Actavis Group Ptc Ehf.

Vivactra Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Malta Actavis Group Ptc Ehf.

Vivactra Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Malta Actavis Group Ptc Ehf.

Vivactra Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Malta Actavis Group Ptc Ehf.

Vivactra Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Malta Actavis Group Ptc Ehf.

Vivactra Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Malta Actavis Group Ptc Ehf.

Vivactra Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Malta Aurobindo Pharma (Malta) Limited

Olmesartan Aurobindo Pharma (Malta)

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Malta Aurobindo Pharma (Malta) Limited

Olmesartan Aurobindo Pharma (Malta)

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Malta Aurobindo Pharma (Malta) Limited

Olmesartan Aurobindo Pharma (Malta)

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 195: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 195/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Malta Aurobindo Pharma (Malta) Limited

Olmesartan/Hydrochlorothiazide Aurobindo Pharma

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Malta Aurobindo Pharma (Malta) Limited

Olmesartan/Hydrochlorothiazide Aurobindo Pharma (Malta)

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Malta Aurobindo Pharma (Malta) Limited

Olmesartan/Hydrochlorothiazide Aurobindo Pharma (Malta)

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Malta Aurobindo Pharma (Malta) Limited

Olmesartan/Hydrochlorothiazide Aurobindo Pharma (Malta)

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Menarini International Operations Luxembourg S.A.

Belfor Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Menarini International Operations Luxembourg S.A.

Belfor Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Netherlands Menarini International Operations Luxembourg S.A.

Belfor Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 196: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 196/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Netherlands Menarini International Operations Luxembourg S.A.

Belfor Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Menarini International Operations Luxembourg S.A.

Belfor Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Menarini International Operations Luxembourg S.A.

Belfor Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Menarini International Operations Luxembourg S.A.

Belfor Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Menarini International Operations Luxembourg S.A.

Belfor Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Apotex Europe B.V. Olmesartan Medoxomil Apotex

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Netherlands Apotex Europe B.V. Olmesartan Medoxomil Apotex

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Netherlands Apotex Europe B.V. Olmesartan Medoxomil Apotex

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 197: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 197/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Netherlands Jubilant Pharmaceuticals Nv

Olmesartan Medoxomil Jubilant

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Netherlands Jubilant Pharmaceuticals Nv

Olmesartan Medoxomil Jubilant

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Netherlands Jubilant Pharmaceuticals Nv

Olmesartan Medoxomil Jubilant

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Netherlands Aurobindo Pharma B.V.

Olmesartanmedoxomil/Hydrochloorthiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Aurobindo Pharma B.V.

Olmesartanmedoxomil/Hydrochloorthiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Aurobindo Pharma B.V.

Olmesartanmedoxomil/Hydrochloorthiazide Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Aurobindo Pharma B.V.

Olmesartanmedoxomil/Hydrochloorthiazide Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Aurobindo Pharma B.V.

Olmesartanmedoxomil Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Netherlands Aurobindo Pharma B.V.

Olmesartanmedoxomil Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Netherlands Aurobindo Pharma B.V.

Olmesartanmedoxomil Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Netherlands Mylan B.V. Olmesartan Medoxomil Mylan

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 198: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 198/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Netherlands Mylan B.V. Olmesartan Medoxomil Mylan

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Netherlands Mylan B.V. Olmesartan Medoxomil Mylan

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Netherlands Ratiopharm Gmbh Olmesartan Medoxomil/Amlodipine Ratiopharm

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Ratiopharm Gmbh Olmesartan Medoxomil/Amlodipine Ratiopharm

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Netherlands Ratiopharm Gmbh Olmesartan Medoxomil/Amlodipine Ratiopharm

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Sevikar Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 199: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 199/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Netherlands Daiichi Sankyo Nederland B.V.

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Olmesartan Medoxomil/Amlodipine Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Olmesartan Medoxomil/Amlodipine Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Olmesartan Medoxomil/Amlodipine Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Olmesartan Medoxomil/Amlodipine/Hct Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Olmesartan Medoxomil/Amlodipine/Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 200: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 200/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Netherlands Daiichi Sankyo Nederland B.V.

Olmesartan Medoxomil/Amlodipine/Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Olmesartan Medoxomil/Amlodipine/Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Olmesartan Medoxomil/Amlodipine/Hct Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Olmetec Hctz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Olmetec Hctz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Olmetec Hctz Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 201: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 201/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Netherlands Daiichi Sankyo Nederland B.V.

Olmetec Hctz Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Nederland B.V.

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Netherlands Glenmark Pharmaceuticals Europe Limited

Olmesartan Medoxomil Glenmark

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Netherlands Glenmark Pharmaceuticals Europe Limited

Olmesartan Medoxomil Glenmark

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Netherlands Glenmark Pharmaceuticals Europe Limited

Olmesartan Medoxomil Glenmark

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Netherlands Centrafarm B.V. Olmesartan Medoxomil/Hct Cf

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Centrafarm B.V. Olmesartan Medoxomil/Hct Cf

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Centrafarm B.V. Olmesartan Medoxomil/Hct Cf

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 202: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 202/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Netherlands Centrafarm B.V. Olmesartan Medoxomil/Hct Cf

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Centrafarm B.V. Olmesartanmedoxomil Cf Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Netherlands Centrafarm B.V. Olmesartanmedoxomil Cf Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Netherlands Centrafarm B.V. Olmesartanmedoxomil Cf Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Netherlands Alembic Pharmaceuticals Europe Ltd

Olmesartan Medoxomil Alembic

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Netherlands Alembic Pharmaceuticals Europe Ltd

Olmesartan Medoxomil Alembic

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Netherlands Alembic Pharmaceuticals Europe Ltd

Olmesartan Medoxomil Alembic

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Netherlands Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochloorthiazide Accord

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochloorthiazide Accord

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochloorthiazide Accord

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 203: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 203/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Netherlands Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochloorthiazide Accord

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Accord Healthcare Limited

Olmesartanmedoxomil/Amlodipine Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Accord Healthcare Limited

Olmesartanmedoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Netherlands Accord Healthcare Limited

Olmesartanmedoxomil/Amlodipine Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Netherlands Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Netherlands Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Netherlands Stada Arzneimittel Ag

Olmesartanmedoxomil/Amlodipine Stada

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Stada Arzneimittel Ag

Olmesartanmedoxomil/Amlodipine Stada

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Netherlands Stada Arzneimittel Ag

Olmesartanmedoxomil/Amlodipine Stada

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Teva Nederland B.V. Olmesartan Medoxomil/Amlodipine Teva

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Teva Nederland B.V. Olmesartan Medoxomil/Amlodipine Teva

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Netherlands Teva Nederland B.V. Olmesartan Medoxomil/Amlodipine Teva

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 204: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 204/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Netherlands Teva Nederland B.V. Olmesartan Medoxomil/Hct Teva

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Teva Nederland B.V. Olmesartan Medoxomil/Hct Teva

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Teva Nederland B.V. Olmesartan Medoxomil/Hct Teva

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Teva Nederland B.V. Olmesartan Medoxomil/Hct Teva

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Teva Nederland B.V. Olmesartan Medoxomil Teva Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Netherlands Teva Nederland B.V. Olmesartan Medoxomil Teva Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Netherlands Teva Nederland B.V. Olmesartan Medoxomil Teva Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Netherlands Sandoz B.V. Olmesartan Medoxomil Sandoz

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Netherlands Sandoz B.V. Olmesartan Medoxomil Sandoz

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Netherlands Sandoz B.V. Olmesartan Medoxomil Sandoz

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Netherlands Sandoz B.V. Olmesartanmedoxomil/Hydrochloorthiazide Sandoz

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 205: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 205/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Netherlands Sandoz B.V. Olmesartanmedoxomil/Hydrochloorthiazide Sandoz

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Sandoz B.V. Olmesartanmedoxomil/Hydrochloorthiazide Sandoz

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Sandoz B.V. Olmesartanmedoxomil/Hydrochloorthiazide Sandoz

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Europe Gmbh

Capenon Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Europe Gmbh

Capenon Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Europe Gmbh

Capenon Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Europe Gmbh

Capenon Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Europe Gmbh

Capenon Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Europe Gmbh

Capenon Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 206: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 206/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Netherlands Daiichi Sankyo Europe Gmbh

Capenon Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Daiichi Sankyo Europe Gmbh

Capenon Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Krka, D.D., Novo Mesto

Olmesartan Medoxomil/Hydrochloorthiazide Krka

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Krka, D.D., Novo Mesto

Olmesartan Medoxomil/Hydrochloorthiazide Krka

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Krka, D.D., Novo Mesto

Olmesartan Medoxomil/Hydrochloorthiazide Krka

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Netherlands Krka, D.D., Novo Mesto

Olmesartan Medoxomil/Hydrochloorthiazide Krka

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Netherlands Krka, D.D., Novo Mesto

Olmesartan Medoxomil Krka Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Netherlands Krka, D.D., Novo Mesto

Olmesartan Medoxomil Krka Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Netherlands Krka, D.D., Novo Mesto

Olmesartan Medoxomil Krka Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 207: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 207/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Norway Menarini International Operations Luxembourg S.A.

Alea Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Norway Menarini International Operations Luxembourg S.A.

Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Norway Menarini International Operations Luxembourg S.A.

Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Norway Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Norway Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Norway Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Norway Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 208: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 208/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Norway Menarini International Operations Luxembourg S.A.

Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Norway Menarini International Operations Luxembourg S.A.

Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Norway Menarini International Operations Luxembourg S.A.

Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Norway Menarini International Operations Luxembourg S.A.

Benetor Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Norway Menarini International Operations Luxembourg S.A.

Benetor Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Norway Menarini International Operations Luxembourg S.A.

Benetor Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Norway Menarini International Operations Luxembourg S.A.

Benetor Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 209: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 209/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Norway Menarini International Operations Luxembourg S.A.

Benetor Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Norway Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Norway Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Norway Accord Healthcare Limited

Olmesartan Medoxomil Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Norway Daiichi Sankyo Europe Gmbh

Olmetec Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Norway Daiichi Sankyo Europe Gmbh

Olmetec Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Norway Daiichi Sankyo Europe Gmbh

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Norway Daiichi Sankyo Europe Gmbh

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Norway Daiichi Sankyo Europe Gmbh

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Norway Daiichi Sankyo Europe Gmbh

Olmetec Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 210: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 210/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Norway Daiichi Sankyo Europe Gmbh

Olmetec Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Norway Daiichi Sankyo Europe Gmbh

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Norway Daiichi Sankyo Europe Gmbh

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Norway Daiichi Sankyo Europe Gmbh

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Norway Krka, D.D., Novo Mesto

Olmesartan Medoxomil/Hydrochlorothiazide Krka

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Norway Krka, D.D., Novo Mesto

Olmesartan Medoxomil/Hydrochlorothiazide Krka

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Norway Krka, D.D., Novo Mesto

Olmesartan Medoxomil Krka Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Norway Krka, D.D., Novo Mesto

Olmesartan Medoxomil Krka Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Norway Krka, D.D., Novo Mesto

Olmesartan Medoxomil Krka Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Poland Menarini International Operations Luxembourg S.A.

Elestar Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 211: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 211/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Poland Menarini International Operations Luxembourg S.A.

Elestar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Poland Menarini International Operations Luxembourg S.A.

Elestar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Poland Menarini International Operations Luxembourg S.A.

Elestar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Poland Menarini International Operations Luxembourg S.A.

Elestar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Poland Menarini International Operations Luxembourg S.A.

Elestar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Poland Menarini International Operations Luxembourg S.A.

Elestar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Poland Menarini International Operations Luxembourg S.A.

Elestar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 212: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 212/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Poland Menarini International Operations Luxembourg S.A.

Revival Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Poland Menarini International Operations Luxembourg S.A.

Revival Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Poland Menarini International Operations Luxembourg S.A.

Revival Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Poland Menarini International Operations Luxembourg S.A.

Revival Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Poland Menarini International Operations Luxembourg S.A.

Revival Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Poland Zentiva, K.S. Osaver Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Poland Zentiva, K.S. Osaver Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 213: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 213/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Poland Zentiva, K.S. Osaver Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Poland Zentiva, K.S. Osaver Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Poland Zentiva, K.S. Osaver Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Poland Zentiva, K.S. Osaver Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Poland Zentiva, K.S. Osaver Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Poland Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmetiaz Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Poland Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmetiaz Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Poland Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmetiaz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 214: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 214/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Poland Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna

Polmetiaz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Poland Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Poland Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Poland Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Poland Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Poland Krka, D.D., Novo Mesto

Olmita Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Poland Krka, D.D., Novo Mesto

Olmita Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Poland Krka, D.D., Novo Mesto

Olmita Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Poland Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Poland Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 215: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 215/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Poland Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Menarini International Operations Luxembourg S.A.

Olsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Menarini International Operations Luxembourg S.A.

Olsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Menarini International Operations Luxembourg S.A.

Zolnor Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Menarini International Operations Luxembourg S.A.

Zolnor Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Menarini International Operations Luxembourg S.A.

Zolnor Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Menarini International Operations Luxembourg S.A.

Zolnor Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 216: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 216/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Menarini International Operations Luxembourg S.A.

Zolnor Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Menarini International Operations Luxembourg S.A.

Zolnor Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Menarini International Operations Luxembourg S.A.

Zolnor Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Menarini International Operations Luxembourg S.A.

Zolnor Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Menarini International Operations Luxembourg S.A.

Olsar Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Menarini International Operations Luxembourg S.A.

Olsar Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Menarini International Operations Luxembourg S.A.

Olsar Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 217: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 217/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Menarini International Operations Luxembourg S.A.

Olsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Menarini International Operations Luxembourg S.A.

Olsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Substipharm Developpement

Davidol Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Substipharm Developpement

Davidol Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Substipharm Developpement

Davidol Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Substipharm Developpement

Davidol Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Substipharm Developpement

Olmesartan Medoxomilo + Hidroclorotiazida Substipharm

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Substipharm Developpement

Olmesartan Medoxomilo + Hidroclorotiazida Substipharm

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 218: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 218/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Substipharm Developpement

Olmesartan Medoxomilo + Hidroclorotiazida Substipharm

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Substipharm Developpement

Olmesartan Medoxomilo + Hidroclorotiazida Substipharm

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Substipharm Developpement

Olmesartan Medoxomilo Substipharm

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Substipharm Developpement

Olmesartan Medoxomilo Substipharm

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Substipharm Developpement

Olmesartan Medoxomilo Substipharm

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Substipharm Developpement

Sathenar Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Substipharm Developpement

Sathenar Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Substipharm Developpement

Sathenar Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Tolife - Produtos Farmacêuticos, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Lumec

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Tolife - Produtos Farmacêuticos, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Lumec

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Tolife - Produtos Farmacêuticos, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Lumec

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 219: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 219/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Tolife - Produtos Farmacêuticos, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Lumec

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Tolife - Produtos Farmacêuticos, S.A.

Olmesartan Medoxomilo Lumec

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Tolife - Produtos Farmacêuticos, S.A.

Olmesartan Medoxomilo Lumec

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Tolife - Produtos Farmacêuticos, S.A.

Olmesartan Medoxomilo Lumec

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Tolife - Produtos Farmacêuticos, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Tolife

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film Coated Tablet Oral Use

Portugal Tolife - Produtos Farmacêuticos, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Tolife

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film Coated Tablet Oral Use

Portugal Tolife - Produtos Farmacêuticos, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Tolife

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Tolife - Produtos Farmacêuticos, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Tolife

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Tolife - Produtos Farmacêuticos, S.A.

Olmesartan Medoxomilo Tolife

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Tolife - Produtos Farmacêuticos, S.A.

Olmesartan Medoxomilo Tolife

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Tolife - Produtos Farmacêuticos, S.A.

Olmesartan Medoxomilo Tolife

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 220: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 220/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Tolife - Produtos Farmacêuticos, S.A.

Amlodipina + Olmesartan Medoxomilo Tolife

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Tolife - Produtos Farmacêuticos, S.A.

Amlodipina + Olmesartan Medoxomilo Tolife

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Tolife - Produtos Farmacêuticos, S.A.

Amlodipina + Olmesartan Medoxomilo Tolife

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.

Olmesartan Medoxomilo + Hidroclorotiazida Pharmakern

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.

Olmesartan Medoxomilo + Hidroclorotiazida Pharmakern

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.

Olmesartan Medoxomilo + Hidroclorotiazida Pharmakern

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.

Olmesartan Medoxomilo + Hidroclorotiazida Pharmakern

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 221: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 221/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.

Olmesartan Medoxomilo Pharmakern

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.

Olmesartan Medoxomilo Pharmakern

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.

Olmesartan Medoxomilo Pharmakern

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Cinfa Portugal, Lda. Olmesartan Medoxomilo Cinfa

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Cinfa Portugal, Lda. Olmesartan Medoxomilo Cinfa

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Cinfa Portugal, Lda. Olmesartan Medoxomilo Cinfa

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Cinfa Portugal, Lda. Amlodipina + Olmesartan Medoxomilo Cinfa

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Cinfa Portugal, Lda. Amlodipina + Olmesartan Medoxomilo Cinfa

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Cinfa Portugal, Lda. Amlodipina + Olmesartan Medoxomilo Cinfa

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 222: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 222/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Cinfa Portugal, Lda. Amlodipina + Olmesartan Medoxomilo Cinfa

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Cinfa Portugal, Lda. Olmesartan Medoxomilo + Hidroclorotiazida Cinfa

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Cinfa Portugal, Lda. Olmesartan Medoxomilo + Hidroclorotiazida Cinfa

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Cinfa Portugal, Lda. Amlodipina + Olmesartan Medoxomilo Cinfa

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Cinfa Portugal, Lda. Olmesartan Medoxomilo + Hidroclorotiazida Cinfa

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Cinfa Portugal, Lda. Olmesartan Medoxomilo + Hidroclorotiazida Cinfa

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Cinfa Portugal, Lda. Olmesartan Medoxomilo + Hidroclorotiazida Cinfa

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Cinfa Portugal, Lda. Olmesartan Medoxomilo + Hidroclorotiazida Cinfa

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Mylan, Lda Olmesartan Medoxomilo + Hidroclorotiazida Mylan

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 13mg Tablet

Film-Coated Tablet Oral Use

Portugal Mylan, Lda Amlodipina + Olmesartan Medoxomilo Mylan

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 223: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 223/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Mylan, Lda Olmesartan Medoxomilo + Hidroclorotiazida Mylan

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Mylan, Lda Olmesartan Medoxomilo + Hidroclorotiazida Mylan

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Mylan, Lda Olmesartan Medoxomilo + Hidroclorotiazida Mylan

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Mylan, Lda Olmesartan Medoxomilo Mylan

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Mylan, Lda Olmesartan Medoxomilo Mylan

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Mylan, Lda Olmesartan Medoxomilo Mylan

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Sandoz Farmacêutica Lda.

Amlodipina + Olmesartan Medoxomilo Sandoz

Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Sandoz Farmacêutica Lda.

Amlodipina + Olmesartan Medoxomilo Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Sandoz Farmacêutica Lda.

Amlodipina + Olmesartan Medoxomilo Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Sandoz Farmacêutica Lda.

Olmesartan + Hidroclorotiazida 1apharma

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 224: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 224/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Sandoz Farmacêutica Lda.

Olmesartan + Hidroclorotiazida 1apharma

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Sandoz Farmacêutica Lda.

Olmesartan + Hidroclorotiazida 1apharma

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Sandoz Farmacêutica Lda.

Olmesartan + Hidroclorotiazida 1apharma

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Sandoz Farmacêutica Lda.

Olmesartan + Hidroclorotiazida 1apharma

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Sandoz Farmacêutica Lda.

Olmesartan + Hidroclorotiazida Sandoz

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Sandoz Farmacêutica Lda.

Olmesartan + Hidroclorotiazida Sandoz

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Sandoz Farmacêutica Lda.

Olmesartan + Hidroclorotiazida Sandoz

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Sandoz Farmacêutica Lda.

Olmesartan + Hidroclorotiazida Sandoz

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Sandoz Farmacêutica Lda.

Olmesartan Medoxomilo Sandoz

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 225: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 225/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Sandoz Farmacêutica Lda.

Olmesartan Medoxomilo Sandoz

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Sandoz Farmacêutica Lda.

Olmesartan Medoxomilo Sandoz

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Sandoz Farmacêutica Lda.

Olmesartan Medoxomilo Sandoz Farmaceutica Lda.

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Sandoz Farmacêutica Lda.

Olmesartan Medoxomilo Sandoz Farmacêutica

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Sandoz Farmacêutica Lda.

Olmesartan Medoxomilo Sandoz Farmaceutica Lda.

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Sandoz Farmacêutica Lda.

Olmesartan Medoxomilo Sandoz Farmacêutica

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Sandoz Farmacêutica Lda.

Olmesartan Medoxomilo Sandoz Farmacêutica

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Teva Pharma – Produtos Farmacêuticos Lda

Olmesartan Medoxomilo Teva

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Teva Pharma – Produtos Farmacêuticos Lda

Olmesartan Medoxomilo Teva

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Teva Pharma – Produtos Farmacêuticos Lda

Olmesartan Medoxomilo Teva

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Teva Pharma – Produtos Farmacêuticos Lda

Olmesartan Medoxomilo Teva

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 226: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 226/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Ciclum Farma Unipessoal Lda.

Amlodipina + Olmesartan Medoxomilo Ciclum

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Ciclum Farma Unipessoal Lda.

Amlodipina + Olmesartan Medoxomilo Ciclum

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Ciclum Farma Unipessoal Lda.

Amlodipina + Olmesartan Medoxomilo Ciclum

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Ciclum Farma Unipessoal Lda.

Amlodipina + Olmesartan Medoxomilo Ciclum

Amlodipine 5mg Tablet, Olmesartan 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Ciclum Farma Unipessoal Lda.

Olmesartan Medoxomilo + Hidroclorotiazida Ciclum

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Ciclum Farma Unipessoal Lda.

Olmesartan Medoxomilo + Hidroclorotiazida Ciclum

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Ciclum Farma Unipessoal Lda.

Olmesartan Medoxomilo + Hidroclorotiazida Ciclum

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Ciclum Farma Unipessoal Lda.

Olmesartan Medoxomilo + Hidroclorotiazida Ciclum

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Ciclum Farma Unipessoal Lda.

Olmesartan Medoxomilo Ciclum

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Ciclum Farma Unipessoal Lda.

Olmesartan Medoxomilo Ciclum

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Ciclum Farma Unipessoal Lda.

Olmesartan Medoxomilo Ciclum

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 227: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 227/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Sanofi - Produtos Farmaceuticos Lda

Olmesartan Medoxomilo + Hidroclorotiazida Zentiva

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Sanofi - Produtos Farmaceuticos Lda

Olmesartan Medoxomilo + Hidroclorotiazida Zentiva

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Sanofi - Produtos Farmaceuticos Lda

Olmesartan Medoxomilo + Hidroclorotiazida Zentiva

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Sanofi - Produtos Farmaceuticos Lda

Olmesartan Medoxomilo + Hidroclorotiazida Zentiva

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Sanofi - Produtos Farmaceuticos Lda

Olmesartan Medoxomilo Zentiva

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Sanofi - Produtos Farmaceuticos Lda

Olmesartan Medoxomilo Zentiva

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Sanofi - Produtos Farmaceuticos Lda

Olmesartan Medoxomilo Zentiva

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Sanofi - Produtos Farmaceuticos Lda

Amlodipina + Olmesartan Medoxomilo Zentiva

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 13.89mg Tablet

Film-Coated Tablet Oral Use

Portugal Sanofi - Produtos Farmaceuticos Lda

Amlodipina + Olmesartan Medoxomilo Zentiva

Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 6.95mg Tablet

Film-Coated Tablet Oral Use

Portugal Sanofi - Produtos Farmaceuticos Lda

Amlodipina + Olmesartan Medoxomilo Zentiva

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 6.95mg Tablet

Film-Coated Tablet Oral Use

Page 228: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 228/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Alter, S.A. Olmesartan Medoxomilo + Hidroclorotiazida Atolme

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Alter, S.A. Olmesartan Medoxomilo + Hidroclorotiazida Atolme

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Alter, S.A. Olmesartan Medoxomilo + Hidroclorotiazida Atolme

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Alter, S.A. Olmesartan Medoxomilo + Hidroclorotiazida Atolme

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Alter, S.A. Olmesartan Medoxomilo + Hidroclorotiazida Alter

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Alter, S.A. Olmesartan Medoxomilo + Hidroclorotiazida Alter

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Alter, S.A. Olmesartan Medoxomilo + Hidroclorotiazida Alter

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Alter, S.A. Olmesartan Medoxomilo + Hidroclorotiazida Alter

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Alter, S.A. Olmesartan Medoxomilo Atolme

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 229: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 229/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Alter, S.A. Olmesartan Medoxomilo Atolme

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Alter, S.A. Olmesartan Medoxomilo Atolme

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Alter, S.A. Olmesartan Medoxomilo Alter

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Alter, S.A. Olmesartan Medoxomilo Alter

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Alter, S.A. Olmesartan Medoxomilo Alter

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Alter, S.A. Amlodipina + Olmesartan Medoxomilo Alter

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Alter, S.A. Amlodipina + Olmesartan Medoxomilo Alter

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Alter, S.A. Amlodipina + Olmesartan Medoxomilo Alter

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Azevedos

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Azevedos

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Azevedos

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 230: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 230/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Azevedos

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Azevedos

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Azevedos

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Azevedos

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Azevedos

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Tad Pharma Gmbh Amlodipina + Olmesartan Medoxomilo Tad

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Tad Pharma Gmbh Amlodipina + Olmesartan Medoxomilo Tad

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Tad Pharma Gmbh Amlodipina + Olmesartan Medoxomilo Tad

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Amlodipina + Olmesartan Medoxomilo + Hidroclorotiazida Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 231: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 231/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Daiichi Sankyo Portugal, Unip. Lda

Amlodipina + Olmesartan Medoxomilo + Hidroclorotiazida Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Amlodipina + Olmesartan Medoxomilo + Hidroclorotiazida Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Amlodipina + Olmesartan Medoxomilo + Hidroclorotiazida Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Amlodipina + Olmesartan Medoxomilo + Hidroclorotiazida Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Amlodipina + Olmesartan Medoxomilo Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Amlodipina + Olmesartan Medoxomilo Daiichi Sankyo

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Amlodipina + Olmesartan Medoxomilo Daiichi Sankyo

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 232: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 232/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Daiichi Sankyo Portugal, Unip. Lda

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Sevikar Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 233: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 233/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 234: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 234/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Daiichi Sankyo Portugal, Unip. Lda

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Teva Pharma – Produtos Farmacêuticos Lda

Olmesartan Medoxomilo + Hidroclorotiazida Teva

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 235: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 235/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Teva Pharma – Produtos Farmacêuticos Lda

Olmesartan Medoxomilo + Hidroclorotiazida Teva

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Teva Pharma – Produtos Farmacêuticos Lda

Olmesartan Medoxomilo + Hidroclorotiazida Teva

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Teva Pharma – Produtos Farmacêuticos Lda

Olmesartan + Hidroclorotiazida Teva

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Teva Pharma – Produtos Farmacêuticos Lda

Olmesartan + Hidroclorotiazida Teva

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Teva Pharma – Produtos Farmacêuticos Lda

Olmesartan + Hidroclorotiazida Teva

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Teva Pharma – Produtos Farmacêuticos Lda

Olmesartan + Hidroclorotiazida Teva

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Teva Pharma – Produtos Farmacêuticos Lda

Olmesartan Medoxomilo + Hidroclorotiazida Teva

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Teva Pharma – Produtos Farmacêuticos Lda

Olmesartan Medoxomilo + Hidroclorotiazida Teva

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Teva Pharma – Produtos Farmacêuticos Lda

Olmesartan Medoxomilo + Hidroclorotiazida Teva

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 236: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 236/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Teva Pharma – Produtos Farmacêuticos Lda

Olmesartan Medoxomilo Teva

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Teva Pharma – Produtos Farmacêuticos Lda

Olmesartan Medoxomilo Teva

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan Medoxomilo + Hidroclorotiazida Ratiopharm

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan Medoxomilo + Hidroclorotiazida Ratiopharm

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan + Hctz Deka Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan + Hctz Deka Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan + Hctz Ratiopharm

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 237: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 237/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan + Hidroclorotiazida Ratiopharm

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan + Hidroclorotiazida Zidrium Ratiopharm

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan + Hidroclorotiazida Zidrium

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan + Hidroclorotiazida Zidrium 40 Ratiopharm

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan Medoxomilo + Amlodipina Ratiopharm

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan Medoxomilo + Amlodipina Ratiopharm

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan Medoxomilo + Amlodipina Ratiopharm

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 238: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 238/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan Medoxomilo + Hidroclorotiazida Ratiopharm

Hydrochlorothiazide 12.5mg Tablet, Olmesartan 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan Medoxomilo + Hidroclorotiazida Ratiopharm

Hydrochlorothiazide 25mg Tablet, Olmesartan 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan Medoxomilo Ratiopharm

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan Medoxomil Ratiopharm

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan Medoxomilo Ratiopharm

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan Medoxomil Ratiopharm

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan Medoxomilo Ratiopharm

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 239: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 239/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan Medoxomil Ratiopharm

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Olmesartan Medoxomil Ratiopharm

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo Pentafarma

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo Pentafarma

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo Pentafarma

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo Pentafarma

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo Pentafarma

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo Pentafarma

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 240: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 240/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo Pentafarma

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo Pentafarma

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo Pentafarma

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo Pentafarma

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo Pentafarma

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo Pentafarma

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo Pentafarma

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo Pentafarma

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo Pentafarma

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 241: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 241/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 242: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 242/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo Farmoz

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo Farmoz

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo Farmoz

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo Farmoz

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo Farmoz

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo Farmoz

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 243: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 243/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo Farmoz

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo Farmoz

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo Farmoz

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo Farmoz

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo Farmoz

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo Farmoz

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo Farmoz

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo Farmoz

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo Farmoz

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 244: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 244/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Farmoz

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Farmoz

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Farmoz

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Farmoz

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Farmoz

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Farmoz

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Farmoz

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Farmoz

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Farmoz

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 245: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 245/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Generis Phar - Promoção De Medicamentos, Unip. Lda.

Olmesartan Medoxomilo + Hidroclorotiazida Labesfal

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Phar - Promoção De Medicamentos, Unip. Lda.

Olmesartan Medoxomilo + Hidroclorotiazida Labesfal

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Phar - Promoção De Medicamentos, Unip. Lda.

Olmesartan Medoxomilo + Hidroclorotiazida Labesfal

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Phar - Promoção De Medicamentos, Unip. Lda.

Olmesartan Medoxomilo + Hidroclorotiazida Labesfal

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 246: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 246/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 247: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 247/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 248: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 248/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 249: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 249/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurobindo

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 250: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 250/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 251: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 251/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 252: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 252/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 253: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 253/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 254: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 254/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 255: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 255/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 256: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 256/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 257: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 257/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurovitas

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurovitas

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurovitas

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurovitas

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurovitas

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurovitas

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurovitas

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 258: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 258/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurovitas

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Aurovitas

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Generis Phar

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Generis Phar

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Generis Phar

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Generis Phar

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Generis Phar

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Generis Phar

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Generis Phar

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 259: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 259/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Generis Phar

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Generis

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Generis

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Generis

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Generis

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Generis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Generis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Generis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Generis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Generis

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 260: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 260/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo + Hidroclorotiazida Generis

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Generis

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Generis Phar

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Generis Phar

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Generis Phar

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Generis Phar

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Generis Phar

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Generis Phar

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Generis Farmacêutica, S.A.

Olmesartan Medoxomilo Generis Phar

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Teva B.V Olmesartan Medoxomilo + Amlodipina Teva

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Teva B.V Olmesartan Medoxomilo + Amlodipina Teva

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Teva B.V Olmesartan Medoxomilo + Amlodipina Teva

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 261: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 261/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Bluepharma Genéricos - Comércio De Medicamentos, S.A.

Amlodipina + Olmesartan Medoxomilo Bluepharma

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Bluepharma Genéricos - Comércio De Medicamentos, S.A.

Amlodipina + Olmesartan Medoxomilo Bluepharma

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Bluepharma Genéricos - Comércio De Medicamentos, S.A.

Amlodipina + Olmesartan Medoxomilo Bluepharma

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Distriquímica, S.A. Olmesartan Medoxomilo Distriquimica

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Distriquímica, S.A. Olmesartan Medoxomilo Distriquimica

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Hetero Europe S.L. Olmesartan Hetero Europe S.L.

Olmesartan 10mg Tablet Film-Coated Tablet Oral Use

Portugal Hetero Europe S.L. Olmesartan Hetero Europe S.L.

Olmesartan 20mg Tablet Film-Coated Tablet Oral Use

Portugal Hetero Europe S.L. Olmesartan Hetero Europe S.L.

Olmesartan 40mg Tablet Film-Coated Tablet Oral Use

Portugal Krka, D.D., Novo Mesto

Amlodipina + Olmesartan Medoxomilo Krka

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Krka, D.D., Novo Mesto

Amlodipina + Olmesartan Medoxomilo Krka

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 262: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 262/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Portugal Krka, D.D., Novo Mesto

Amlodipina + Olmesartan Medoxomilo Krka

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Portugal Krka, D.D., Novo Mesto

Olmesartan Medoxomilo + Hidroclorotiazida Krka

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Krka, D.D., Novo Mesto

Olmesartan Medoxomilo + Hidroclorotiazida Krka

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Krka, D.D., Novo Mesto

Olmesartan Medoxomilo + Hidroclorotiazida Krka

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Portugal Krka, D.D., Novo Mesto

Olmesartan Medoxomilo + Hidroclorotiazida Krka

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Portugal Krka, D.D., Novo Mesto

Olmesartan Medoxomilo Krka

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Portugal Krka, D.D., Novo Mesto

Olmesartan Medoxomilo Krka

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Portugal Krka, D.D., Novo Mesto

Olmesartan Medoxomilo Krka

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Romania Menarini International Operations Luxembourg S.A.

Inovum Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 263: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 263/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Romania Menarini International Operations Luxembourg S.A.

Inovum Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Romania Menarini International Operations Luxembourg S.A.

Inovum Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Menarini International Operations Luxembourg S.A.

Inovum Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Romania Menarini International Operations Luxembourg S.A.

Inovum Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Romania Menarini International Operations Luxembourg S.A.

Inovum Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Romania Menarini International Operations Luxembourg S.A.

Inovum Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Romania Menarini International Operations Luxembourg S.A.

Inovum Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 264: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 264/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Romania Berlin-Chemie Ag Santini Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Romania Berlin-Chemie Ag Santini Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Romania Berlin-Chemie Ag Santini Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Romania Hcs Bvba Olssa Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Hcs Bvba Olssa Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Romania Hcs Bvba Olssa Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 265: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 265/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 266: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 266/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 267: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 267/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5μg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Romania Alvogen Malta Operations (Row) Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 268: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 268/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipina Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 5mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipina Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 10mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipina Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 5mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 269: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 269/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 270: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 270/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 271: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 271/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Romania Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipină Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania S.C. Sandoz S.R.L. Olmesartan Medoxomil/Amlodipină Sandoz

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania S.C. Sandoz S.R.L. Olmesartan Medoxomil/Amlodipină Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Romania S.C. Sandoz S.R.L. Olmesartan Medoxomil/Amlodipină Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Terapia S.A. Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 272: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 272/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Romania Terapia S.A. Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Romania Terapia S.A. Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Romania Terapia S.A. Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Romania Terapia S.A. Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Romania Terapia S.A. Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Romania Terapia S.A. Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Romania Terapia S.A. Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Romania Zentiva, K.S. Olmesartan Medoxomil/Amlodipină Zentiva

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Romania Zentiva, K.S. Olmesartan Medoxomil/Amlodipină Zentiva

Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 6.95mg Tablet

Film-Coated Tablet Oral Use

Romania Zentiva, K.S. Olmesartan Medoxomil/Amlodipină Zentiva

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 13.89mg Tablet

Film-Coated Tablet Oral Use

Romania Zentiva, K.S. Olmesartan Medoxomil/Amlodipină Zentiva

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 6.95mg Tablet

Film-Coated Tablet Oral Use

Page 273: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 273/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Romania Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Romania Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Romania Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Romania Krka, D.D., Novo Mesto

Olmicombi Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12500μg Tablet

Film-Coated Tablet Oral Use

Romania Krka, D.D., Novo Mesto

Olmicombi Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Romania Krka, D.D., Novo Mesto

Olmicombi Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12500μg Tablet

Film-Coated Tablet Oral Use

Romania Krka, D.D., Novo Mesto

Olmicombi Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Slovakia Menarini International Operations Luxembourg S.A.

Folgan Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Slovakia Menarini International Operations Luxembourg S.A.

Folgan Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 274: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 274/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Slovakia Menarini International Operations Luxembourg S.A.

Folgan Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Slovakia Menarini International Operations Luxembourg S.A.

Folgan Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Slovakia Menarini International Operations Luxembourg S.A.

Folgan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Slovakia Menarini International Operations Luxembourg S.A.

Folgan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Slovakia Menarini International Operations Luxembourg S.A.

Folgan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Slovakia Menarini International Operations Luxembourg S.A.

Folgan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Slovakia Menarini International Operations Luxembourg S.A.

Tenzar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 275: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 275/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Slovakia Menarini International Operations Luxembourg S.A.

Tenzar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Slovakia Menarini International Operations Luxembourg S.A.

Tenzar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Slovakia Menarini International Operations Luxembourg S.A.

Tenzar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Slovakia Menarini International Operations Luxembourg S.A.

Tenzar Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Slovakia Menarini International Operations Luxembourg S.A.

Tenzar Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Slovakia Menarini International Operations Luxembourg S.A.

Tenzar Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Slovakia Stada Arzneimittel Ag

Olmestad Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 276: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 276/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Slovakia Stada Arzneimittel Ag

Olmestad Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Slovakia Stada Arzneimittel Ag

Olmestad Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Slovakia Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Slovakia Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Slovakia Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Slovakia Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Slovakia Krka, D.D., Novo Mesto

Olmita Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Slovakia Krka, D.D., Novo Mesto

Olmita Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Slovakia Krka, D.D., Novo Mesto

Olmita Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Slovakia Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Slovakia Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 277: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 277/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Slovakia Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Slovenia Menarini International Operations Luxembourg S.A.

Co-Tensiol Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Slovenia Menarini International Operations Luxembourg S.A.

Co-Tensiol Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Slovenia Menarini International Operations Luxembourg S.A.

Olectan Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Slovenia Menarini International Operations Luxembourg S.A.

Olectan Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Slovenia Menarini International Operations Luxembourg S.A.

Olectan Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Slovenia Menarini International Operations Luxembourg S.A.

Olectan Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 278: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 278/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Slovenia Menarini International Operations Luxembourg S.A.

Olectan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Slovenia Menarini International Operations Luxembourg S.A.

Olectan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Slovenia Menarini International Operations Luxembourg S.A.

Olectan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Slovenia Menarini International Operations Luxembourg S.A.

Olectan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Slovenia Menarini International Operations Luxembourg S.A.

Co-Tensiol Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Slovenia Menarini International Operations Luxembourg S.A.

Co-Tensiol Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Slovenia Menarini International Operations Luxembourg S.A.

Tensiol Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 279: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 279/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Slovenia Menarini International Operations Luxembourg S.A.

Tensiol Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Slovenia Menarini International Operations Luxembourg S.A.

Tensiol Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Slovenia Sandoz Pharmaceuticals D.D.

Medoksomilolmesartanat/Amlodipin Sandoz

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Slovenia Sandoz Pharmaceuticals D.D.

Medoksomilolmesartanat/Amlodipin Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Slovenia Sandoz Pharmaceuticals D.D.

Medoksomilolmesartanat/Amlodipin Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Slovenia Krka, D.D., Novo Mesto

Olmicombi Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Slovenia Krka, D.D., Novo Mesto

Olmicombi Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12500μg Tablet

Film-Coated Tablet Oral Use

Slovenia Krka, D.D., Novo Mesto

Olmicombi Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Slovenia Krka, D.D., Novo Mesto

Olmicombi Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 280: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 280/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Slovenia Krka, D.D., Novo Mesto

Olmicombi Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12500μg Tablet

Film-Coated Tablet Oral Use

Slovenia Krka, D.D., Novo Mesto

Olmicombi Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Slovenia Krka, D.D., Novo Mesto

Olmita Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Slovenia Krka, D.D., Novo Mesto

Olmita Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Slovenia Krka, D.D., Novo Mesto

Olmita Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Slovenia Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Slovenia Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Slovenia Krka, D.D., Novo Mesto

Olimestra Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Menarini International Operations Luxembourg S.A.

Balzak Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Menarini International Operations Luxembourg S.A.

Balzak Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 281: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 281/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Menarini International Operations Luxembourg S.A.

Balzak Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Menarini International Operations Luxembourg S.A.

Balzak Plus Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Menarini International Operations Luxembourg S.A.

Balzak Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Menarini International Operations Luxembourg S.A.

Balzak Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Menarini International Operations Luxembourg S.A.

Balzak Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Menarini International Operations Luxembourg S.A.

Balzak Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Menarini International Operations Luxembourg S.A.

Ixia Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 282: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 282/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Menarini International Operations Luxembourg S.A.

Ixia Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Menarini International Operations Luxembourg S.A.

Ixia Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Menarini International Operations Luxembourg S.A.

Ixia Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Menarini International Operations Luxembourg S.A.

Ixia Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Menarini International Operations Luxembourg S.A.

Ixia Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Menarini International Operations Luxembourg S.A.

Ixia Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Astron Research Limited

Olmesartan Medoxomil/Amlodipine Astron

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Page 283: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 283/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Astron Research Limited

Olmesartan Medoxomil/Amlodipine Astron

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Spain Astron Research Limited

Olmesartan Medoxomil/Amlodipine Astron

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Swan Pond Investments Limited

Olmesartan Nasdo Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Swan Pond Investments Limited

Olmesartan Nasdo Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Swan Pond Investments Limited

Olmesartan Nasdo Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Swan Pond Investments Limited

Olmesartan Spi Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Swan Pond Investments Limited

Olmesartan Spi Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Swan Pond Investments Limited

Olmesartan Spi Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Swan Pond Investments Limited

Olmesartan Swanpond Investments

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Swan Pond Investments Limited

Olmesartan Swanpond Investments

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Swan Pond Investments Limited

Olmesartan Swanpond Investments

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Swan Pond Investments Limited

Olmesartan/Hidroclorotiazida Nasdo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 284: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 284/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Swan Pond Investments Limited

Olmesartan/Hidroclorotiazida Nasdo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Swan Pond Investments Limited

Olmesartan/Hidroclorotiazida Nasdo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Swan Pond Investments Limited

Olmesartan/Hidroclorotiazida Nasdo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Apotex Europe B.V. Olmesartán/Hidroclorotiazida Apotex

Hydrochlorothiazide 25mg Tablet, Olmesartan 20mg Tablet

Tablet Oral

Spain Apotex Europe B.V. Olmesartán/Hidroclorotiazida Apotex

Hydrochlorothiazide 12.5mg Tablet, Olmesartan 40mg Tablet

Tablet Oral

Spain Apotex Europe B.V. Olmesartán/Hidroclorotiazida Apotex

Hydrochlorothiazide 25mg Tablet, Olmesartan 40mg Tablet

Tablet Oral

Spain Apotex Europe B.V. Olmesartán Apotex Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Apotex Europe B.V. Olmesartán Apotex Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Apotex Europe B.V. Olmesartán Apotex Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Apotex Europe B.V. Olmesartán/Hidroclorotiazida Apotex

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 285: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 285/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Macleods Pharma España, S.L.U

Olmesartan Medoxomil Macleods Pharma España, S.L.U.

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Macleods Pharma España, S.L.U

Olmesartan Medoxomil Macleods Pharma España, S.L.U.

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Macleods Pharma España, S.L.U

Olmesartan Medoxomil Macleods Pharma España, S.L.U.

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Qualigen, S.L. Olmesartán Qualigen Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Qualigen, S.L. Olmesartán Qualigen Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Qualigen, S.L. Olmesartán Qualigen Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Qualigen, S.L. Olmesartan/Hidroclorotiazida Qualigen

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Qualigen, S.L. Olmesartan/Hidroclorotiazida Qualigen

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Qualigen, S.L. Olmesartan/Hidroclorotiazida Qualigen

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Qualigen, S.L. Olmesartan/Hidroclorotiazida Qualigen

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 286: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 286/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Tecnimede España Ind. Fca., S.A.

Olmesartán Tecnigen Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Tecnimede España Ind. Fca., S.A.

Olmesartán Tecnigen Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Tecnimede España Ind. Fca., S.A.

Olmesartán Tecnigen Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Tecnimede España Ind. Fca., S.A.

Olmesartán/Hidroclorotiazida Tecnigen

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Tecnimede España Ind. Fca., S.A.

Olmesartán/Hidroclorotiazida Tecnigen

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Tecnimede España Ind. Fca., S.A.

Olmesartán/Hidroclorotiazida Tecnigen

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Tecnimede España Ind. Fca., S.A.

Olmesartán/Hidroclorotiazida Tecnigen

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Aurovitas Spain,s.A.U.

Olmesartán/Hidroclorotiazida Aurovitas

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Aurovitas Spain,s.A.U.

Olmesartán/Hidroclorotiazida Aurovitas

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Aurovitas Spain,s.A.U.

Olmesartán Aurovitas Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 287: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 287/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Aurovitas Spain,s.A.U.

Olmesartán Aurovitas Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Aurovitas Spain,s.A.U.

Olmesartán Aurovitas Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Aurovitas Spain,s.A.U.

Olmesartán/Hidroclorotiazida Aurovitas

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Aurovitas Spain,s.A.U.

Olmesartán/Hidroclorotiazida Aurovitas

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Pfizer, S.L. Capenon Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Pfizer, S.L. Capenon Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Pfizer, S.L. Capenon Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Pfizer, S.L. Capenon Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 288: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 288/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Pfizer, S.L. Capenon Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo España, S.A.

Capenon Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo España, S.A.

Capenon Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo España, S.A.

Capenon Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo España, S.A.

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo España, S.A.

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo España, S.A.

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo España, S.A.

Sevikar Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo España, S.A.

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 289: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 289/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Daiichi Sankyo España, S.A.

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo España, S.A.

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo España, S.A.

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo España, S.A.

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo España, S.A.

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo España, S.A.

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo España, S.A.

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo España, S.A.

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 290: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 290/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Daiichi Sankyo España, S.A.

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo España, S.A.

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo España, S.A.

Openvas Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo España, S.A.

Openvas Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo España, S.A.

Openvas Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Combix, S.L.U.

Olmesartán Combix Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Combix, S.L.U.

Olmesartán Combix Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Combix, S.L.U.

Olmesartán Combix Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Combix, S.L.U.

Olmesartán/Hidroclorotiazida Combix

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Combix, S.L.U.

Olmesartán/Hidroclorotiazida Combix

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Combix, S.L.U.

Olmesartán/Hidroclorotiazida Combix

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 291: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 291/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Laboratorios Combix, S.L.U.

Olmesartán/Hidroclorotiazida Combix

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Aurobindo S.L.U.

Olmesartán/Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Aurobindo S.L.U.

Olmesartán/Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Aurobindo S.L.U.

Olmesartán/Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Aurobindo S.L.U.

Olmesartán/Hidroclorotiazida Aurobindo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Aurobindo S.L.U.

Olmesartán Aurobindo Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Aurobindo S.L.U.

Olmesartán Aurobindo Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Aurobindo S.L.U.

Olmesartán Aurobindo Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Pensa Pharma, S.A.U.

Olmesartán Pensa Pharma Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Pensa Pharma, S.A.U.

Olmesartán Pensa Pharma Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Pensa Pharma, S.A.U.

Olmesartán Pensa Pharma Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 292: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 292/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Pensa Pharma, S.A.U.

Olmesartán/Hidroclorotiazida Pensa Pharma

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Pensa Pharma, S.A.U.

Olmesartán/Hidroclorotiazida Pensa Pharma

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg / 25 Tablet

Film-Coated Tablet Oral Use

Spain Pensa Pharma, S.A.U.

Olmesartán/Hidroclorotiazida Pensa Pharma

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Pensa Pharma, S.A.U.

Olmesartán/Hidroclorotiazida Pensa Pharma

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Pensa Pharma, S.A.U.

Olmesartán/Amlodipino Pensa

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Spain Pensa Pharma, S.A.U.

Olmesartán/Amlodipino Pensa

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Pensa Pharma, S.A.U.

Olmesartán/Amlodipino Pensa

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Mylan Pharmaceuticals S.L.

Olmesartan/Hidroclorotiazida Mylan

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Mylan Pharmaceuticals S.L.

Olmesartan/Hidroclorotiazida Mylan

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Mylan Pharmaceuticals S.L.

Olmesartan/Hidroclorotiazida Mylan

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 293: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 293/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Mylan Pharmaceuticals S.L.

Olmesartan/Hidroclorotiazida Mylan

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Mylan Pharmaceuticals S.L.

Olmesartán Mylan Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Mylan Pharmaceuticals S.L.

Olmesartán Mylan Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Mylan Pharmaceuticals S.L.

Olmesartán Mylan Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Sandoz Farmacéutica, S.A.

Olmesartán Sandoz Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Sandoz Farmacéutica, S.A.

Olmesartán Sandoz Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Sandoz Farmacéutica, S.A.

Olmesartán Sandoz Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Sandoz Farmacéutica, S.A.

Olmesartán/Hidroclorotiazida Sandoz

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Sandoz Farmacéutica, S.A.

Olmesartán/Hidroclorotiazida Sandoz

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Sandoz Farmacéutica, S.A.

Olmesartán/Hidroclorotiazida Sandoz

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Sandoz Farmacéutica, S.A.

Olmesartán/Hidroclorotiazida Sandoz

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 294: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 294/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Aristo Pharma Iberia, S.L.

Olmesartan Hibes Aristo Pharma Iberia

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Aristo Pharma Iberia, S.L.

Olmesartan Hibes Aristo Pharma Iberia

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Aristo Pharma Iberia, S.L.

Olmesartan Hibes Aristo Pharma Iberia

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Ratiopharm España S.A.,

Olmesartan/Amlodipino Ratiopharm

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Ratiopharm España S.A.,

Olmesartan/Amlodipino Ratiopharm

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Spain Ratiopharm España S.A.,

Olmesartan/Amlodipino Ratiopharm

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Ratiopharm España S.A.,

Olmesartán Ratiopharm Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Ratiopharm España S.A.,

Olmesartán Ratiopharm Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Ratiopharm España S.A.,

Olmesartán/Hidroclorotiazida Ratio

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Ratiopharm España S.A.,

Olmesartán/Hidroclorotiazida Ratio

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Ratiopharm España S.A.,

Olmesartán/Hidroclorotiazida Ratio

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 295: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 295/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Ratiopharm España S.A.,

Olmesartán/Hidroclorotiazida Ratio

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Ratiopharm España S.A.,

Olmesartan Ratiopharm Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Teva Pharma S.L.U., Olmesartán/Hidroclorotiazida Tevagen

Hydrochlorothiazide 12.5mg Tablet, Olmesartan 20mg Tablet

Film-Coated Tablet Oral Use

Spain Teva Pharma S.L.U., Olmesartan Tevagen Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Teva Pharma S.L.U., Olmesartan Tevagen Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Teva Pharma S.L.U., Olmesartán Tevagen Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Teva Pharma S.L.U., Olmesartán/Hidroclorotiazida Tevagen

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Teva Pharma S.L.U., Olmesartán/Hidroclorotiazida Tevagen

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Teva Pharma S.L.U., Olmesartán/Hidroclorotiazida Tevagen

Hydrochlorothiazide 25mg Tablet, Olmesartan 40mg Tablet

Film-Coated Tablet Oral Use

Spain Sandoz Farmacéutica, S.A.

Olmesartán/Amlodipino Sandoz

Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 5mg Tablet

Film-Coated Tablet Oral Use

Page 296: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 296/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Sandoz Farmacéutica, S.A.

Olmesartán/Amlodipino Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 10mg Tablet

Film-Coated Tablet Oral Use

Spain Sandoz Farmacéutica, S.A.

Olmesartán/Amlodipino Sandoz

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 5mg Tablet

Film-Coated Tablet Oral Use

Spain Tedec-Meiji Farma, S.A.

Olmesartán Meiji Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Tedec-Meiji Farma, S.A.

Olmesartán Meiji Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Tedec-Meiji Farma, S.A.

Olmesartán Meiji Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Mabo-Farma, S.A. Olmesartan/Hidroclorotiazida Mabo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Mabo-Farma, S.A. Olmesartan/Hidroclorotiazida Mabo

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Mabo-Farma, S.A. Olmesartan/Hidroclorotiazida Mabo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Mabo-Farma, S.A. Olmesartan/Hidroclorotiazida Mabo

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Mabo-Farma, S.A. Olmesartán Mabo-Farma Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 297: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 297/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Mabo-Farma, S.A. Olmesartán Mabo-Farma Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Mabo-Farma, S.A. Olmesartán Mabo-Farma Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Cinfa, S.A.

Olmesartán Cinfa Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral

Spain Laboratorios Cinfa, S.A.

Olmesartán Cinfa Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral

Spain Laboratorios Cinfa, S.A.

Olmesartán Cinfa Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral

Spain Laboratorios Cinfa, S.A.

Olmesartán / Hidroclorotiazida Cinfa

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Cinfa, S.A.

Olmesartán / Hidroclorotiazida Cinfa

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Cinfa, S.A.

Olmesartán / Hidroclorotiazida Cinfa

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Cinfa, S.A.

Olmesartán / Hidroclorotiazida Cinfa

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Cinfa, S.A.

Olmesartán/Amlodipino Cinfa

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Cinfa, S.A.

Olmesartán/Amlodipino Cinfa

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 298: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 298/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Laboratorios Cinfa, S.A.

Olmesartán/Amlodipino Cinfa

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorio Stada, S.L.

Olmesartán Stada Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorio Stada, S.L.

Olmesartán Stada Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorio Stada, S.L.

Olmesartán Stada Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorio Stada, S.L.

Olmesartán/Amlodipino Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorio Stada, S.L.

Olmesartán/Amlodipino Amlodipine 10mg Tablet, Olmesartan 40mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorio Stada, S.L.

Olmesartán/Amlodipino Amlodipine 5mg Tablet, Olmesartan 40mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorio Stada, S.L.

Olmesartán/Hidroclorotiazida Stada

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorio Stada, S.L.

Olmesartán/Hidroclorotiazida Stada

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorio Stada, S.L.

Olmesartán/Hidroclorotiazida Stada

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorio Stada, S.L.

Olmesartán/Hidroclorotiazida Stada

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 299: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 299/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Laboratorio Stada, S.L.

Olmesartán/Hidroclorotiazida Stadagen

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorio Stada, S.L.

Olmesartán/Hidroclorotiazida Stadagen

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorio Stada, S.L.

Olmesartán/Hidroclorotiazida Stadagen

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorio Stada, S.L.

Olmesartán/Hidroclorotiazida Stadagen

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Tarbis Farma, S.L. Olmesartán Tarbis Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Tarbis Farma, S.L. Olmesartán Tarbis Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Tarbis Farma, S.L. Olmesartán Tarbis Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Tarbis Farma, S.L. Olmesartán/Hidroclorotiazida Tarbis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Tarbis Farma, S.L. Olmesartán/Hidroclorotiazida Tarbis

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Tarbis Farma, S.L. Olmesartán/Hidroclorotiazida Tarbis

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 300: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 300/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Tarbis Farma, S.L. Olmesartán/Hidroclorotiazida Tarbis

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Hcs Bvba Olmesartán/Amlodipino Hcs Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Hcs Bvba Olmesartán/Amlodipino Hcs Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Spain Hcs Bvba Olmesartán/Amlodipino Hcs Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Tad Pharma Gmbh Olmesartán/Amlodipino Tad Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Tad Pharma Gmbh Olmesartán/Amlodipino Tad Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Spain Tad Pharma Gmbh Olmesartán/Amlodipino Tad Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Glenmark Pharmaceuticals S.R.O.

Olmesartán/Hidroclorotiazida Viso Farmacéutica

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Glenmark Pharmaceuticals S.R.O.

Olmesartán/Hidroclorotiazida Viso Farmacéutica

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Glenmark Pharmaceuticals S.R.O.

Olmesartán/Hidroclorotiazida Viso Farmacéutica

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Glenmark Pharmaceuticals S.R.O.

Olmesartán/Hidroclorotiazida Viso Farmacéutica

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 301: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 301/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Industria Química Y Farmaceútica Vir, S.A.

Olmesartán Vir Olmesartan Medoxomil 40mg Tablet

Film Coated Tablet Oral Use

Spain Industria Química Y Farmaceútica Vir, S.A.

Olmesartán Vir Olmesartan Medoxomil 20mg Tablet

Film Coated Tablet Oral Use

Spain Industria Química Y Farmaceútica Vir, S.A.

Olmesartán Vir Olmesartan Medoxomil 10mg Tablet

Film Coated Tablet Oral Use

Spain Industria Química Y Farmaceútica Vir, S.A.

Olmesartán / Hidroclorotiazida Vir

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Industria Química Y Farmaceútica Vir, S.A.

Olmesartán / Hidroclorotiazida Vir

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Industria Química Y Farmaceútica Vir, S.A.

Olmesartán / Hidroclorotiazida Vir

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Industria Química Y Farmaceútica Vir, S.A.

Olmesartán / Hidroclorotiazida Vir

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Glenmark Pharmaceuticals Europe Limited

Olmesartán Viso Farmacéutica

Olmesartan Medoxomil 10mg Tablet

Coated Tablet Oral Use

Spain Glenmark Pharmaceuticals Europe Limited

Olmesartán Viso Farmacéutica

Olmesartan Medoxomil 20mg Tablet

Coated Tablet Oral Use

Page 302: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 302/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Glenmark Pharmaceuticals Europe Limited

Olmesartán Viso Farmacéutica

Olmesartan Medoxomil 40mg Tablet

Coated Tablet Oral Use

Spain Laboratorios Alter, S.A.

Atolme Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Alter, S.A.

Atolme Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Alter, S.A.

Atolme Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Alter, S.A.

Atolme Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Alter, S.A.

Olmesartan/Hidroclorotiazida Alter

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Alter, S.A.

Olmesartan/Hidroclorotiazida Alter

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Alter, S.A.

Olmesartan/Hidroclorotiazida Alter

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Alter, S.A.

Olmesartan/Hidroclorotiazida Alter

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 303: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 303/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Laboratorios Alter, S.A.

Atolme Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Alter, S.A.

Atolme Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Alter, S.A.

Atolme Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Alter, S.A.

Olmesartán Alter Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Alter, S.A.

Olmesartán Alter Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Alter, S.A.

Olmesartán Alter Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Alter, S.A.

Albis Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Alter, S.A.

Albis Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Alter, S.A.

Albis Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Alter, S.A.

Olmesartán/Amlodipino Alter Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Alter, S.A.

Olmesartán/Amlodipino Alter Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Alter, S.A.

Olmesartán/Amlodipino Alter Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Kern Pharma, S.L. Olmesartan/Hidroclorotiazida Kern Pharma

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 304: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 304/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Kern Pharma, S.L. Olmesartan/Hidroclorotiazida Kern Pharma

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Kern Pharma, S.L. Olmesartan/Hidroclorotiazida Kern Pharma

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Kern Pharma, S.L. Olmesartan/Hidroclorotiazida Kern Pharma

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Kern Pharma, S.L. Olmesartán Kern Pharma Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Kern Pharma, S.L. Olmesartán Kern Pharma Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Kern Pharma, S.L. Olmesartán Kern Pharma Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Kern Pharma, S.L. Olmesartán/Amlodipino Kern Pharma

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Kern Pharma, S.L. Olmesartán/Amlodipino Kern Pharma

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Spain Kern Pharma, S.L. Olmesartán/Amlodipino Kern Pharma

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Normon, S.A.

Olmesartán/Hidroclorotiazida Gobens

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral

Spain Laboratorios Normon, S.A.

Olmesartán/Hidroclorotiazida Normon

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 305: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 305/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Laboratorios Normon, S.A.

Olmesartán/Hidroclorotiazida Normon

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Normon, S.A.

Olmesartán/Hidroclorotiazida Gobens

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Normon, S.A.

Olmesartán/Hidroclorotiazida Gobens

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Normon, S.A.

Olmesartán/Hidroclorotiazida Gobens

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Normon, S.A.

Olmesartán/Hidroclorotiazida Normon

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Normon, S.A.

Olmesartán Normon Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Normon, S.A.

Olmesartán Normon Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Normon, S.A.

Olmesartán Normon Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Normon, S.A.

Olmesartán/Hidroclorotiazida Normon

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Normon, S.A.

Olmesartán/Amlodipino Normon

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Page 306: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 306/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Laboratorios Normon, S.A.

Olmesartán/Amlodipino Normon

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Laboratorios Normon, S.A.

Olmesartán/Amlodipino Normon

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Teva B.V Olmesartan/Amlodipino Teva Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Teva B.V Olmesartan/Amlodipino Teva Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Spain Teva B.V Olmesartan/Amlodipino Teva Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Distriquímica, S.A. Olmesartán Distriquimica Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Distriquímica, S.A. Olmesartán Distriquimica Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Zentiva, K.S. Olmesartán Zentiva Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Zentiva, K.S. Olmesartán Zentiva Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Zentiva, K.S. Olmesartán/Hidroclorotiazida Zentiva

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Zentiva, K.S. Olmesartán/Hidroclorotiazida Zentiva

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Zentiva, K.S. Olmesartán/Hidroclorotiazida Zentiva

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 307: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 307/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Zentiva, K.S. Olmesartán/Hidroclorotiazida Zentiva

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Zentiva, K.S. Olmesartán Zentiva Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Accord Healthcare S.L.U.

Olmesartán Medoxomilo/Amlodipino Accord

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Accord Healthcare S.L.U.

Olmesartán Medoxomilo/Amlodipino Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

Spain Accord Healthcare S.L.U.

Olmesartán Medoxomilo/Amlodipino Accord

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

Spain Accord Healthcare S.L.U.

Olmesartan Medoxomilo/Hidroclorotiazida Accord

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Accord Healthcare S.L.U.

Olmesartan Medoxomilo/Hidroclorotiazida Accord

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Accord Healthcare S.L.U.

Olmesartan Medoxomilo/Hidroclorotiazida Accord

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Accord Healthcare S.L.U.

Olmesartan Medoxomilo/Hidroclorotiazida Accord

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 308: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 308/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Accord Healthcare S.L.U.

Olmesartan Medoxomilo Accord

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Accord Healthcare S.L.U.

Olmesartan Medoxomilo Accord

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Accord Healthcare S.L.U.

Olmesartan Medoxomilo Accord

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo Europe Gmbh

Openvas Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo Europe Gmbh

Openvas Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo Europe Gmbh

Openvas Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Daiichi Sankyo Europe Gmbh

Openvas Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 309: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 309/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Spain Krka, D.D., Novo Mesto

Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Krka, D.D., Novo Mesto

Olmesartán Krka Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Krka, D.D., Novo Mesto

Olmesartán Krka Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Krka, D.D., Novo Mesto

Olmesartán Krka Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Spain Krka, D.D., Novo Mesto

Olmesartán/Hidroclorotiazida Krka

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Krka, D.D., Novo Mesto

Olmesartán/Hidroclorotiazida Krka

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Krka, D.D., Novo Mesto

Olmesartán/Hidroclorotiazida Krka

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Spain Krka, D.D., Novo Mesto

Olmesartán/Hidroclorotiazida Krka

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Spain Krka, D.D., Novo Mesto

Olseron Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Spain Krka, D.D., Novo Mesto

Olseron Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Spain Krka, D.D., Novo Mesto

Olseron Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 310: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 310/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

Sweden Jubilant Pharmaceuticals Nv

Olmesartan Jubilant Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Sweden Jubilant Pharmaceuticals Nv

Olmesartan Jubilant Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Sweden Jubilant Pharmaceuticals Nv

Olmesartan Jubilant Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Substipharm Developpement

Davidol Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Substipharm Developpement

Davidol Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Substipharm Developpement

Davidol Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Substipharm Developpement

Davidol Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Substipharm Developpement

Olmesartan Medoxomil Substipharm Developpement

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Substipharm Developpement

Olmesartan Medoxomil Substipharm Developpement

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Substipharm Developpement

Olmesartan Medoxomil Substipharm Developpement

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

Page 311: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 311/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

United Kingdom Milpharm Limited Olmesartan Milpharm Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Milpharm Limited Olmesartan Milpharm Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Milpharm Limited Olmesartan Milpharm Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Jubilant Pharmaceuticals Nv

Olmesartan Medoxomil Jubilant Pharmaceuticals Nv

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Jubilant Pharmaceuticals Nv

Olmesartan Medoxomil Jubilant Pharmaceuticals Nv

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Jubilant Pharmaceuticals Nv

Olmesartan Medoxomil Jubilant Pharmaceuticals

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Teva Uk Limited Olmesartan Medoxomil/Hydrochlorothiazide Teva

Hydrochlorothiazide 12.5mg Tablet, Olmesartan 20mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Teva Uk Limited Olmesartan Medoxomil/Hydrochlorothiazide Teva

Hydrochlorothiazide 25mg Tablet, Olmesartan 20mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Teva Uk Limited Olmesartan Medoxomil/Hydrochlorothiazide Teva

Hydrochlorothiazide 12.5mg Tablet, Olmesartan 40mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Teva Uk Limited Olmesartan Medoxomil/Hydrochlorothiazide Teva Uk

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Teva Uk Limited Olmesartan Medoxomil Teva Uk

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 312: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 312/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

United Kingdom Teva Uk Limited Olmesartan Medoxomil Teva Uk

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Teva Uk Limited Olmesartan Medoxomil Teva Uk

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Daiichi Sankyo Uk Ltd

Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Daiichi Sankyo Uk Ltd

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Daiichi Sankyo Uk Ltd

Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Daiichi Sankyo Uk Ltd

Sevikar Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Daiichi Sankyo Uk Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Daiichi Sankyo Uk Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Daiichi Sankyo Uk Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

Page 313: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 313/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

United Kingdom Daiichi Sankyo Uk Ltd

Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Daiichi Sankyo Uk Ltd

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Daiichi Sankyo Uk Ltd

Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Daiichi Sankyo Uk Ltd

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Daiichi Sankyo Uk Ltd

Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Daiichi Sankyo Uk Ltd

Olmetec Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Daiichi Sankyo Uk Ltd

Olmetec Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Daiichi Sankyo Uk Ltd

Olmetec Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Glenmark Pharmaceuticals Europe Limited

Olmesartan Medoxomil Glenmark

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 314: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 314/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

United Kingdom Glenmark Pharmaceuticals Europe Limited

Olmesartan Medoxomil Glenmark

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Glenmark Pharmaceuticals Europe Limited

Olmesartan Medoxomil Glenmark

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Thornton & Ross Ltd Olmesartan/Hydrochlorothiazide Stada

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Thornton & Ross Ltd Olmesartan/Hydrochlorothiazide Stada

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Thornton & Ross Ltd Olmesartan/Hydrochlorothiazide Stada

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Thornton & Ross Ltd Olmesartan/Hydrochlorothiazide Stada

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Thornton & Ross Ltd Olmesartan Stada Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Thornton & Ross Ltd Olmesartan Stada Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Thornton & Ross Ltd Olmesartan Stada Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Winthrop Pharmaceuticals Uk Ltd

Olmesartan Winthrop Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 315: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 315/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

United Kingdom Winthrop Pharmaceuticals Uk Ltd

Olmesartan Winthrop Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Winthrop Pharmaceuticals Uk Ltd

Olmesartan Winthrop Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Winthrop Pharmaceuticals Uk Ltd

Olmesartan/Amlodipine Winthrop

Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 6.95mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Winthrop Pharmaceuticals Uk Ltd

Olmesartan/Amlodipine Winthrop

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 13.89mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Winthrop Pharmaceuticals Uk Ltd

Olmesartan/Amlodipine Winthrop

Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 6.95mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Actavis Group Ptc Ehf.

Olmesartan Actavis Group Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Actavis Group Ptc Ehf.

Olmesartan Actavis Group Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Actavis Group Ptc Ehf.

Olmesartan Actavis Group Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochlorothiazide Accord Healthcare

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochlorothiazide Accord Healthcare

Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

Page 316: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 316/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

United Kingdom Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochlorothiazide Accord Healthcare

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Accord Healthcare Limited

Olmesartan Medoxomil/Hydrochlorothiazide Accord Healthcare

Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Accord Healthcare Limited

Olmesartan Medoxomil Accord Healthcare

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord Healthcare

Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord Healthcare

Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Accord Healthcare Limited

Olmesartan Medoxomil/Amlodipine Accord Healthcare

Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Accord Healthcare Limited

Olmesartan Medoxomil Accord Healthcare

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Accord Healthcare Limited

Olmesartan Medoxomil Accord Healthcare

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Generics [uk] Limited Olmesartan Medoxomil Generics Uk

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Generics [uk] Limited Olmesartan Medoxomil Generics Uk

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Generics [uk] Limited Olmesartan Medoxomil Generics Uk

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

Page 317: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 317/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

United Kingdom Torrent Pharma Gmbh

Olmesartan Torrent Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Torrent Pharma Gmbh

Olmesartan Torrent Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Torrent Pharma Gmbh

Olmesartan Torrent Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Distriquímica, S.A. Olmesartan Distriquimica Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Distriquímica, S.A. Olmesartan Distriquimica Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Distriquímica, S.A. Olmesartan Distriquimica Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Crescent Pharma Limited

Olmesartan Medoxomil Crescent Pharma

Olmesartan Medoxomil 10μg Tablet

Film-Coated Tablet Oral Use

United Kingdom Crescent Pharma Limited

Olmesartan Medoxomil Crescent Pharma

Olmesartan Medoxomil 20μg Tablet

Film-Coated Tablet Oral Use

United Kingdom Crescent Pharma Limited

Olmesartan Medoxomil Crescent Pharma

Olmesartan Medoxomil 40μg Tablet

Film-Coated Tablet Oral Use

United Kingdom Macleods Pharma Uk Ltd

Olmesartan Macleods Pharma Uk

Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Macleods Pharma Uk Ltd

Olmesartan Medoxomil Macleods Pharma Uk

Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Macleods Pharma Uk Ltd

Olmesartan Medoxomil Macleods Pharma Uk

Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Krka, D.D., Novo Mesto

Olmesartan Krka Olmesartan Medoxomil 10mg Tablet

Film-Coated Tablet Oral Use

Page 318: Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318 Member State in EEA

List of medicines affected by the referral procedure EMA/662763/2018 Page 318/318

Member State in EEA

Marketing authorisaton holder

Product name INN + Strength Pharmaceutical form Route of administration

United Kingdom Krka, D.D., Novo Mesto

Olmesartan Krka Olmesartan Medoxomil 20mg Tablet

Film-Coated Tablet Oral Use

United Kingdom Krka, D.D., Novo Mesto

Olmesartan Krka Olmesartan Medoxomil 40mg Tablet

Film-Coated Tablet Oral Use


Recommended