1
LISTof the medicines recommended for the registration by the Center according to the meeting decision N 8-2/19 on August 30, 2019
N Trade name
International non-proprietary (generic) names or names of active substances
dosage form dosage strength
& output form (packaging)
Manufacturer country License holder License holder country
Prescription status
Conclusion N & date
1.Olestezin-AV
concentrate of sea buckthorn oil,
sulfaetidol, benzocaine
suppositories rectal
330mg+50mg+100mg; (10/2x5/)
Altayvitaminy CJSC, 659325,
Altay region, Biysk, st.
Zavodskaya, 69
Russia
Altayvitaminy CJSC, 659325,
Altay region, Biysk, st.
Zavodskaya, 69
Russia OTC 18731 30.08.2019
2.Tonofungyn fluconazole capsules hard 150mg; (2/2x1/)
in strip
Egyptian International
Pharmaceutical Industries Company
(EIPICO), 10th of Ramadan City, Industrial Area B1,P.O. box 149,Tenth
Egypt
Egyptian International
Pharmaceutical Industries Company
(EIPICO), 10th of Ramadan
City, Industrial Area B1,P.O. box 149,Tenth
Egypt R 18732 30.08.2019
3.Bifren phenybut capsules
250mg; (20/2x10/) in
blister
Pharma Start LLC, Boulevard
Vatslava Havela, 8, 03124, Kiev
Ukraine
Acino Ukraine LLC, Boulevard
Vatslava Havela, 8,
03124, Kiev
Ukraine R 18733 30.08.2019
President___________________E. Amroya
2
4.Zetoptic brinzolamide, timolol
(timolol maleate) drops eye
(suspension)
10mg/ml+5mg/ml; plastic vial
5ml
Liqvor CJSC, 0089, Yerevan, str. Kochinyan,
7/9
Republic of Armenia
Liqvor CJSC, 0089, Yerevan, str. Kochinyan,
7/9
Republic of Armenia R 18734
30.08.2019
5.Riidor cefepime (cefepime
hydrochloride)
powder for solution for injection or
infusion
1000mg; (1) and (50) glass vial
15ml
PharmaTech CJSC, 0064,
Yerevan, Raffi str. 111-batch releaser,
secondary packager, Topico Pharmaceuticals Pvt. Ltd., Plot 38,
Kukatpally, Hyderabad,
Telagana, India-bulk
manufacturer, primary packager
Republic of Armenia
PharmaTech CJSC, 0064,
Yerevan, Raffi str. 111
Republic of Armenia R 18735
30.08.2019
6.Actria cefotaxime
(cefotaxime sodium)
powder for solution for injection or
infusion
1000mg; (1) and (50) glass vial
10ml
PharmaTech CJSC, 0064,
Yerevan, Raffi str. 111-batch releaser,
secondary packager, Topico Pharmaceuticals Pvt. Ltd., Plot 38,
Kukatpally, Hyderabad,
Telagana, India-bulk
manufacturer, primary packager
Republic of Armenia
PharmaTech CJSC, 0064,
Yerevan, Raffi str. 111
Republic of Armenia R 18736
30.08.2019
7.Sintuss butamirate
(butamirate citrate) syrup 7.5mg/5ml; 200ml glass bottle and
Vetprom AD, Otez Paissij str. 26,
Radomir 2400 for
Bulgaria Vetprom AD,
Otez Paissij str. 26, Radomir
Bulgaria OTC 18737 30.08.2019
3
measuring cup Dahnson-BG Co Ltd., Otez Paissij str. 26, Radomir 2400, Bulgaria
2400 for Dahnson-BG Co
Ltd., Otez Paissij str. 26, Radomir 2400,
Bulgaria
8.Ornitine Canon
ornithine (ornithine aspartate)
granules for oral solution
3000mg; (30) sachets 5g
CJSC Canonpharma
production, 105, Zarechnaya str. 141100 Moskow
region, Schelkovo
Russia
CJSC Canonpharma
production, 105, Zarechnaya str. 141100 Moskow
region, Schelkovo
Russia OTC 18738 30.08.2019
9.Brimoptic
timolol (timolol maleate), brimonidine (brimonidine tartrate)
drops eye 5mg/ml+2mg/ml;
vial-dropper 10ml
Liqvor CJSC, 0089, Yerevan, str. Kochinyan,
7/9
Republic of Armenia
Liqvor CJSC, 0089, Yerevan, str. Kochinyan,
7/9
Republic of Armenia R 18739
30.08.2019
10.Pantoprazole
Canon
pantoprazole (pantoprazole sodium
sesquihydrate)
tablets gastro-resistant
40mg; (28/4x7/) in blister
CJSC Canonpharma
production, 105, Zarechnaya str. 141100 Moskow
region, Schelkovo
Russia
CJSC Canonpharma
production, 105, Zarechnaya str. 141100 Moskow
region, Schelkovo
Russia R 18740 30.08.2019
11.Pantoprazole
Canon
pantoprazole (pantoprazole sodium
sesquihydrate)
tablets gastro-resistant
20mg; (28/4x7/) in blister
CJSC Canonpharma
production, 105, Zarechnaya str. 141100 Moskow
region, Schelkovo
Russia
CJSC Canonpharma
production, 105, Zarechnaya str. 141100 Moskow
region, Schelkovo
Russia OTC 18741 30.08.2019
12.Losartan losartan (losartan
potassium) tablets film-
coated
50mg; (10/1x10/),
(20/2x10/) and (30/3x10/) in
Belmedpreparaty RUE, 220006,
Minsk, Mayakovskogo st.
Belarus Belmedpreparaty RUE, 220007,
Minsk, Fabritsius St.,
Belarus R 18742 30.08.2019
4
blister 1/5 No6 30
13.Panzynorm forte 20 000
pancreatin (lipase, amylase, protease)
tablets gastro-resistant, coated
20000U+12000U+900U;
(10/1x10/) and (30/3x10/) in
blister
KRKA d.d., Novo mesto, Smarjeska
cesta 6, 8501 Novo Mesto
Slovenia
KRKA d.d., Novo mesto,
Smarjeska cesta 6, 8501 Novo
Mesto
Slovenia OTC 18743 30.08.2019
14.Maviret glecaprevir,
pibrentasvir tablets film-
coated
100mg+40mg; (84(4x21(7x3))
in blister
AbbVie Deutschland
GmbH & Co. KG, Knolstrasse,
67061 Ludwigshafen - batch releaser,
packager, quality control, Fournier
Laboratories Ireland Limited,
Anngrove, Carrigtwohill, Co.
Cork, Ireland- bulk manufacturer
Germany
AbbVie Biopharmaceutic
als GmbH, Neuhofstrasse 23, 6341 Baar
Switzerland R 18744 30.08.2019
15.Olazol
hippopheae oil, chloramphenicol, benzocaine, boric
acid
aerosol for external use
0,09g/g+0,027g/g+0,027g/g+0,0045g/g; 60g and 80g aluminium
container
Altayvitaminy CJSC, 659325,
Altay region, Biysk, st.
Zavodskaya, 69
Russia
Altayvitaminy CJSC, 659325,
Altay region, Biysk, st.
Zavodskaya, 69
Russia OTC 18745 30.08.2019
16.Zolacef 1g cefazolin (cefazolin
sodium)
powder for solution for injection or
infusion
1000mg; (1) and (50) glass vial
10ml
PharmaTech CJSC, 0064,
Yerevan, Raffi str. 111-batch releaser,
secondary packager, Topico Pharmaceuticals Pvt. Ltd., Plot 38,
Kukatpally, Hyderabad,
Republic of Armenia
PharmaTech CJSC, 0064,
Yerevan, Raffi str. 111
Republic of Armenia R 18746
30.08.2019
5
Telagana, India-bulk
manufacturer, primary packager
17.Lasolvan ambroxol (ambroxol
hydrochloride) tablets
30mg; (20/2x10/) and (50/5x10/) in
blister
Boehringer Ingelheim Ellas A.E., 5th km,
Paiania-Markopoulo, 194
00 Koropi
Greece
Sanofi-Aventis Deutschland
GmbH, Industriepark
Hoechst, Bruningstrasse 50, D-65926 , Frankfurt am
Main
Germany OTC 18747 30.08.2019
18.Lamictal lamotrigine tablets
100mg; (30/3x10/) in
blister
GlaxoSmithKline Pharmaceuticals
S.A.,189 Grunwaldzka street, 60-322
Poznan
Poland
GlaxoSmithKline Trading CJSC,
119180, Moscow,
Yakimanskaya nab., 2
Russia R 18748 30.08.2019
19.Vitamin C 500 ascorbic acid, sodium
ascorbate tablets
chewable
199.5mg+300.5mg; (10/1x10/), (20/2x10/) and (100/10x10/) in blister, (10) in
blister, (30) and (50) in plastic
container
Pharmaceutical Company
Zdorovye LLC, 22 Shevchenko str., Kharkov, 61013
Ukraine
Pharmaceutical Company
Zdorovye LLC, 22 Shevchenko str., Kharkov,
61013
Ukraine OTC 18749 30.08.2019
20.Topepsil topiramate tablets film-
coated
100mg; (28/2x14) in
blister
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-120-batch
releaser, packager, Generis
Farmaceutica, S.A., Rua Joao de
Hungary
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi ut 30-38
Hungary R 18750 30.08.2019
6
Deus, N 19, Venda Nova,
2700-487 Amadora,
Portugal-bulk manufacturer
21.Topepsil topiramate tablets film-
coated
25mg; (28/2x14/) in
blister
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-120-batch
releaser, packager, Generis
Farmaceutica, S.A., Rua Joao de
Deus, N 19, Venda Nova,
2700-487 Amadora,
Portugal-bulk manufacturer
Hungary
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi ut 30-38
Hungary R 18751 30.08.2019
22.
Celestoderm-V with
Garamycin
betamethasone (betamethasone
valerate), gentamicin (gentamicin sulfate)
ointment 1mg/g+1mg/g; 30g aluminium
tube
Schering-Plough Labo N.V.,
Industriepark 30 B-2220, Heist-op-
den-Berg
Belgium
Schering-Plough Central East
AG, Weystrasse 20, P.O. Box
CH-6000 Lucerne 6
Switzerland R 18752 30.08.2019
23.Biotaksim cefotaxime
(cefotaxime sodium)
powder for solution for i/m
and i/v injection
1000mg; (1) glass vial 10ml
Biosintez PJSC, Druzhby st. 4,
440033, Penza Russia
Biosintez PJSC, Druzhby st. 4,
440033, Penza Russia R 18753
30.08.2019
7
24.Corvitin quercetine, povidon
lyophilisate for solution for
injection
0,05g+0,45g; (5) glass vial
SIC "Borshchahivskiy
Chemical-Pharmaceutical Plant" PJSC, 17,
Mira St, Kyiv, 03134
Ukraine
SIC "Borshchahivski
y Chemical-Pharmaceutical Plant" PJSC, 17,
Mira St, Kyiv, 03134
Ukraine R 18756 30.08.2019
25.Korold-Asteria
paracetamol, pseudoephedrine (pseudoephedrine
hydrochloride), chlorphenamine (chlorphenamine
maleate)
tablets film-coated
500mg+30mg+2mg; (20/2x10/)
and (100/10x10/) in
blister
Hankook Korus Pharm Co., Ltd, 30, Gangjeo-ro,
Jecheon-si, Chungcheongbuk-
do
Korea South
GL Corporation, Woori Venture
Tower #201, 70, Seonyu-ro,
Yeongdeungpo-ku, Seoul
South Korea OTC 18757 30.08.2019
1
LIST of the medicines recommended for the registration under simplified procedure by the Center according to the meeting decision N 8-2/19
on August 30, 2019
N Trade name
International non-proprietary (generic) names or names of active substances
dosage form dosage strength
& output form (packaging)
Manufacturer country License holder License holder country
Pres-cription status
Conclusion N & date
Dexmedeto
midine
dexmedetomidine
(dexmedetomidine
hydrochloride)
concentrate
for solution
for infusion
100mcg/ml;
(5) ampoules
2ml
EVER Pharma
Jena GmbH,
Otto-Schott-
Strasse 15,
07745 Jena
Germany
EVER Valinject
GmbH,
Oberburgau 3,
4866 Unterach
am Attersee
Austria
President___________________E. Amroya
1
LISTof the medicines recommended for the re-registration by the Center according to the meeting decision N 8-2/19 on August 30, 2019
N Trade name
International non-proprietary (generic) names or names of active substances
dosage form dosage strength &
output form (packaging)
Manufacturer country License holder License holder country
Prescrip-tion sta-
tus
Conclusion N & date
1.Phenobarbital phenobarbital tablets 100mg; (48/2x24/)
in blister
Arpimed LLC, Kotayk Marz, Abovyan, 2nd
Micro-District, 19 Building
Republic of Armenia
Arpimed LLC, Kotayk Marz, Abovyan, 2nd
Micro-District, 19 Building
Republic of Armenia R 18758
30.08.2019
2.
Calcium gluconate stabilized
calcium gluconate solution for injection
100mg/ml; (5) ampoules 10ml, (10) ampoules 10ml, (5/1x5/)
ampoules 10ml in blister, (10/2x5/)
ampoules 10ml in blister
PJSC "Farmak", 74 Frunze str., Kiev, 04080 for PJSC "Farmak", 63 Frunze str., Kiev, 04080,
Ukraine
Ukraine
PJSC "Farmak", 74 Frunze str., Kiev, 04080 for PJSC
"Farmak", 63 Frunze str., Kiev, 04080, Ukraine
Ukraine R 18759 30.08.2019
3.
Calcium gluconate stabilisate
calcium gluconate solution for injection
100mg/ml; (5) ampoules 5ml, (10) ampoules 5ml, (5/1x5/)
ampoules 5ml in blister, (10/2x5/) ampoules 5ml in
blister
PJSC "Farmak", 74 Frunze str.,
Kiev, 04080 Ukraine
PJSC "Farmak", 63 Frunze str., Kiev,
04080 Ukraine R 18760
30.08.2019
President___________________E. Amroya
2
4. Norditropin
NordiLet somatropin solution for s/c injection
6,7mg/ml; pre-filled pen 1,5ml
Novo Nordisk A/S, Novo Alle, DK-
2880 Bagsvaerd - batch releaser
(bulk manufacturer,
packager - Novo Nordisk A/S,
Denmark Hagedornsvej 1,
DK-2820 Gentofte, Denmark)
Denmark Novo Nordisk A/S,
Novo Alle, DK-2880 Bagsvaerd
Denmark R 18761 30.08.2019
5. Paclitaxel
Ebewe paclitaxel concentrate for solution for infusion
6mg/ml; (1) glass vial 5ml
EBEWE Pharma Ges. m.b.H. Nfg.
KG, Mondseestrasse
11, A-4866 Unterach am
Attersee
Austria
EBEWE Pharma Ges. m.b.H. Nfg.
KG, Mondseestrasse 11,
A-4866 Unterach am Attersee
Austria R 18762 30.08.2019
6. Paclitaxel
Ebewe paclitaxel concentrate for solution for infusion
6mg/ml; (1) glass vial 25ml
EBEWE Pharma Ges. m.b.H. Nfg.
KG, Mondseestrasse
11, A-4866 Unterach am
Attersee
Austria
EBEWE Pharma Ges. m.b.H. Nfg.
KG, Mondseestrasse 11,
A-4866 Unterach am Attersee
Austria R 18763 30.08.2019
7. Paclitaxel
Ebewe paclitaxel concentrate for solution for infusion
6mg/ml; (1) glass vial 16,7ml
EBEWE Pharma Ges. m.b.H. Nfg.
KG, Mondseestrasse
11, A-4866 Unterach am
Attersee
Austria
EBEWE Pharma Ges. m.b.H. Nfg.
KG, Mondseestrasse 11,
A-4866 Unterach am Attersee
Austria R 18764 30.08.2019
8. Norvasc amlodipine
(amlodipine tablets 5mg; (30/3x10/)
blisters R-Pharm
Germany GmbH, Heinrich-Mack-
Germany Pfizer H.C.P.
Corporation, 235, East 42nd street,
USA R 18765 30.08.2019
3
besilate) Str. 35, 89257, Illertissen
New York 10017
9.Norvasc
amlodipine (amlodipine
besilate) tablets 10mg; (30/3x10/)
in blister
R-Pharm Germany GmbH, Heinrich-Mack-Str. 35, 89257,
Illertissen
Germany
Pfizer H.C.P. Corporation, 235, East 42nd street, New York 10017
USA R 18766 30.08.2019
10.Solpadeine
Active paracetamol,
caffeine tablets soluble
500mg+65mg; (12/2x6/) in strip
Famar A.V.E. Anthoussa Plant, Anthousa Avenue
7, Anthousa Attikis, 15344
Greece
GlaxoSmithKline Consumer
Healhtcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8
9GS
UK OTC 18767 30.08.2019
1
LIST of variations requiring reformulation of registration certificate approved by the Center according to the meeting decision N 8-2/19
on August 30, 2019
N Trade name
International non-proprietary (generic) names or names of active substances
dosage form
dosage strength & output form (packaging)
Manufacturer country License holder License holder country
Prescrip-tion sta-
tus
Conclusion N & date
1.Tricor fenofibrate tablets film-
coated
145mg; (30/3x10/) in
blister
Recipharm Fontaine, Rue des Pres Potets, 21121 Fontaine les Dijon-
batch releaser, packager, Fournier Laboratories Ireland Limited, Anngrove, Carrigtwohill, Co.
Cork, Ireland- bulk manufacturer
France
Abbott Laboratories
GmbH, Freundallee 9A, 30173 Hannover
Germany R 17395/1 30.08.2019
2.Zovirax aciclovir cream for
external use
50mg/g; 2g aluminium
tube
Glaxo Operations UK Limited, Harmire
Road, Barnard Castle, Co Durham
DL12 8DT
UK
GlaxoSmithKline Consumer
Healhtcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8
9GS
UK OTC 14764/1 30.08.2019
3.Femilex lactic acid suppositories
vaginal 100mg;
(10/2x5/) Nizhpharm JSC, 603950, Nizhny
Novgorod,
Russia Nizhpharm JSC, 603950, Nizhny
Novgorod, Salganskaya st.,
Russia OTC 18158/1 30.08.2019
President___________________E. Amroya
2
Salganskaya st., 7 7
4.Amiodarone
amiodarone (amiodarone
hydrochloride)
concentrate for solution for
infusion
50mg/ml; (10) ampoules 3ml, in blister, (10) ampoules 3ml label banderol, (10) ampoules 3ml dividella
Open joint stock company
"Borisovskiy zavod medicinskikh
preparatov", 64, No11/1, ul.
Chapaeva, Borisov, Minsk region
Belarus
Open joint stock company
"Borisovskiy zavod
medicinskikh preparatov", 64, ul. Chapaeva, Borisov, Minsk
region
Belarus R 17535/1 30.08.2019
5.Aksastrol anastrozole tablets film-
coated
1mg; (28/2x14/)
blisters
Remedica Ltd, Limassol Industrial Estate, Aharnon
street, 3056 Limassol
Cyprus Grindeks JSC,
Krustpils str. 53, LV-1057, Riga
Latvia R 14372/1 30.08.2019
6.Kestine ebastine tablets film-
coated
20mg; (10/1x10/) in
blister
Industrias Farmaceuticas
Almirall S.A., Ctra. Nacional II, Km. 593, 08740 Sant
Andreu de la Barca, Barcelona
Spain
Almirall, S.A., Ronda General
Mitre, 151, 08022
Barcelona
Spain R 16992/1 30.08.2019
7.Neuromultivit vitamin B1, vitamin
B6, vitamin B12 tablets film-
coated
100mg+200mg+0,2mg;
(20/1x20/) in blister,
(100/5x20/) in blister,
(20/2x10/) in blister,
(100/10x10/) in blister
G.L. Pharma GmbH,
Schlossplatz 1, 8502 Lannach -
batch releaser, G.L. Pharma GmbH,
Industriestrasse 1, 8502 Lannach, Austria -bulk
manufacturer, packager
Austria
VALEANT LLC, Shabolovka st. 31, building 5,
115162, Moscow
Russia OTC 18344/1 30.08.2019
8.Citramon P
acetylsalicylic acid, paracetamol, caffeine
(caffeine
tablets 240mg+180mg+30mg; (10), (10/1x10/) and
Pharmstandard-Leksredstva JSC,
305022, Kursk,
Russia Pharmstandard-
Leksredstva JSC, 305022,
Russia OTC 17387/1 30.08.2019
3
monohydrate) (20/2x10/) in blister
Agregatnaya 2nd str., 1a/18
Kursk, Agregatnaya
2nd str., 1a/18
9.
AMBROLYTIN 15mg/5ml
syrup
ambroxol (ambroxol hydrochloride) syrup
15mg/5ml; glass bottle 100ml and
plastic measuring cup, plastic bottle 100ml and plastic
measuring cup
Sopharma JSC, str. Iliensko shosse 16, 1220 Sofia - batch
releaser, Sopharma JSC, Vrabevo vlg.
5660, district of Lovetch, Bulgaria-bulk manufacturer,
packager
Bulgaria
Sopharma JSC, str. Iliensko
shosse 16, 1220 Sofia
Bulgaria ԱԴ 15460/2 30.08.2019
10.Aciclovir-Akri aciclovir tablets
200mg; (20/2x10/)
blisters
Akrikhin JSC, 142450, Moscow region, Noginsk district, Staraya Kupavna, Kirova
street 29
Russia
Akrikhin JSC, 142450,
Moscow region, Noginsk district,
Staraya Kupavna, Kirova
street 29
Russia R 14414/1 30.08.2019
11.Aciclovir-Akri aciclovir tablets
400mg; (20/2x10/)
blisters
Akrikhin JSC, 142450, Moscow region, Noginsk district, Staraya Kupavna, Kirova
street 29
Russia
Akrikhin JSC, 142450,
Moscow region, Noginsk district,
Staraya Kupavna, Kirova
street 29
Russia R 14415/1 30.08.2019
12.Betaserc
betahistine (betahistine
dihydrochloride) tablets
8mg; (30/1x30/) in
blister
Mylan Laboratories SAS, Route de
Belleville, Lieu-dit Maillard, 01400
Chatillon sur Chalaronne
France
Abbott Healthcare
Products B.V., C.J. van
Houtenlaan 36, NL-1381 CP
Weesp,
the Netherlands R 17656/1
30.08.2019
13.Betaserc betahistine
(betahistine tablets 16mg;
(30/2x15/) in
Mylan Laboratories SAS, Route de
Belleville, Lieu-dit
France Abbott
Healthcare Products B.V.,
the Netherlands R 17657/1
30.08.2019
4
dihydrochloride) blister Maillard, 01400 Chatillon sur Chalaronne
C.J. van Houtenlaan 36,
NL-1381 CP Weesp
14.Betaserc
betahistine (betahistine
dihydrochloride) tablets
24mg; (20/1x20/) and (60/3x20/) in
blister
Mylan Laboratories SAS, Route de
Belleville, Lieu-dit Maillard, 01400
Chatillon sur Chalaronne
France
Abbott Healthcare
Products B.V., C.J. van
Houtenlaan 36, NL-1381 CP
Weesp
the Netherlands R 17655/1
30.08.2019
15.Cordarone
amiodarone (amiodarone
hydrochloride) tablets
200mg; (30/2x15/) in
blister
Chinoin Pharmaceutical and
Chemical Works Private Co. Ltd.,
2112 Veresegyhaz, Levai u. 5,
Hungary
Sanofi-Aventis France, 1-13,
boulevard Romain Rolland,
75014 Paris
France R 15080/2 30.08.2019
16.
Fentavera 50mcg/h
transdermal patch
fentanyl patch transdermal
50mcg/h; (5) patches
Acino AG, Am Windfeld 35, 83714 Miesbach - batch
releaser, Luye Pharma AG, Am
Windfeld 27 und 35, 83714 Miesbach, Germany - bulk manufacturer,
packager
Germany Acino AG, Am Windfeld 35,
83714 Miesbach Germany R 13834/1
30.08.2019
17.
Fentavera 75mcg/h
transdermal patch
fentanyl patch transdermal
75mcg/h; (5) patches
Acino AG, Am Windfeld 35, 83714 Miesbach - batch
releaser, Luye Pharma AG, Am
Windfeld 27 und 35, 83714 Miesbach, Germany - bulk manufacturer,
packager
Germany Acino AG, Am Windfeld 35,
83714 Miesbach Germany R 13835/1
30.08.2019
1
LISTof the variations not requiring reformulation of registration certificate approved by the Center according to the meeting decision N 8-2/19 on
August 30, 2019
N Trade name
International non-proprietary (generic) names or names of active substances
dosage form
dosage strength & output form (packaging)
Manufacturer country License holder License holder country
Prescrip-tion sta-
tus
Conclusion N & date
1.Tobradex tobramycin,
dexamethasone drops eye
(suspension)
3mg/ml+1mg/ml; 5ml plastic
vial
S.A. Alcon-Couvreur N.V.,
Rijksweg 14 2870 Puurs
Belgium Novartis Pharma
AG, Lichtstrasse 35, 4056 Basel,
Switzerland R 18048/1 30.08.2019
2.Maxidex dexamethasone drops eye
(suspension)
1mg/ml; 5ml plastic
dropper-vial
S.A. Alcon-Couvreur N.V.,
Rijksweg 14 2870 Puurs
Belgium Novartis Pharma
AG, Lichtstrasse 35, 4056 Basel
Switzerland R 18183/1 30.08.2019
3.
Mydocalm solution for
injection
tolperisone (tolperisone
hydrochloride), lidocaine (lidocaine
hydrochloride)
solution for injection
100mg/ml+2,5mg/ml; (5)
ampoules 1ml
Gedeon Richter PLC, Gyomroi ut
19-21, 1103 Budapest
Hungary
Gedeon Richter PLC, Gyomroi ut
19-21, 1103 Budapest
Hungary R 14427/1 30.08.2019
4.CalciD-Denk
calcium (calcium carbonate),
colecalciferol
tablets effervescent
1000mg+22mcg(880IU); (20)
in plastic container
Losan Pharma GmbH, Otto- Hahn-Strasse 13,15, 79395
Neuenburg for Germany
Denk Pharma GmbH & Co. KG, Prinzregentenstr.
79, 81675 Muenchen
Germany R 16831/2 30.08.2019
President___________________E. Amroya
2
5.Silkaderm tretinoin cream
0,5mg/g; aluminum tube
15g
Arpimed LLC, Kotayk Marz, Abovyan, 2nd
Micro-District, 19 Building
Republic of Armenia
Arpimed LLC, Kotayk Marz, Abovyan, 2nd
Micro-District, 19 Building
Republic of Armenia OTC 13552/1
30.08.2019
6.Floxaton
levofloxacin (levofloxacin hemihydrate)
tablets film-coated
500mg; (10/1x10/) in
blister
Medochemie Ltd., (Central Factory),
1-10 Constantinoupole
os street, 3011 Limassol
Cyprus
Medochemie Ltd., 1-10
Constantinoupoleos street, 3011
Limassol
Cyprus R 18249/1 30.08.2019
7.Cetrotide cetrorelix (cetrorelix
acetate)
powder lyophilized for solution for s/c
injection
0,25mg; N7 glass vials with
powder, N7 prefilled
syringes with solvent 1ml, N14 needles, N14 alcohol swabs; N1
glass vials with powder, N1
prefilled syringes with
solvent 1ml, N 2 needles, N 2 alcohol swabs
Baxter Oncology GmbH,
Kantstrasse 2, Halle/Westfalen,
33790
Germany
Merck Serono Europe Ltd., Marsh
Wall 56, London E14 9TP
UK R 15782/2 30.08.2019
8.Vametal
ondansetron (ondansetron hydrochloride
dihydrate)
solution for i/v and i/m injection
2mg/ml; glass vial 4ml
Help S.A., Pedini Ioanninon,
Ioannina, 45500 Greece
Medicus S.A., 10 Valaoritou str., GR
144 52, Metamorphosis,
Attika
Greece R 14112/2 30.08.2019
9.Vametal
ondansetron (ondansetron hydrochloride
dihydrate)
solution for i/v and i/m injection
2mg/ml; glass vial 2ml
Help S.A., Pedini Ioanninon,
Ioannina, 45500 Greece
Medicus S.A., 10 Valaoritou str., GR
144 52, Metamorphosis,
Attika
Greece R 14114/2 30.08.2019
3
10. Vametal
ondansetron (ondansetron hydrochloride
dihydrate)
tablets film-coated
8mg; (15/3x5/) blisters
Help S.A., Pedini Ioanninon,
Ioannina, 45500 Greece
Medicus S.A., 10 Valaoritou str., GR
144 52, Metamorphosis,
Attika
Greece R 14113/2 30.08.2019
11. Herbion
plantain syrup
liquid aqueous extract of the narrowleaf
plantain leaves, liquid aqueous extract of
the common mallow flower, ascorbic acid
syrup
1250mg/5ml+1250mg/5ml+65mg/5ml; 150ml
glass bottle and measuring
spoon
KRKA d.d., Novo mesto, Smarjeska
cesta 6, 8501 Novo Mesto-batch releaser, KRKA, tovarna zdravil,
d.d., Novo mesto,Povhova ulica 5,
8501 Novo Mesto, Slovenia-bulk manufacturer,
packager
Slovenia
KRKA d.d., Novo mesto, Smarjeska
cesta 6, 8501 Novo Mesto
Slovenia OTC 16497/1 30.08.2019
12. Glycerin glycerol suppositories
rectal
1,24g; (10/2x5/) in
blister
Nizhpharm JSC, 603950, Nizhny
Novgorod, Salganskaya st., 7
Russia
Nizhpharm JSC, 603950, Nizhny
Novgorod, Salganskaya st., 7
Russia OTC 17035/1 30.08.2019
13. Glycerin glycerol suppositories
rectal
2.11g; (10/2x5/) in
blister
Nizhpharm JSC, 603950, Nizhny
Novgorod, Salganskaya st., 7
Russia
Nizhpharm JSC, 603950, Nizhny
Novgorod, Salganskaya st., 7
Russia OTC 17036/1 30.08.2019
14. Naklofen diclofenac (diclofenac
sodium) solution for
injection 75mg/3ml; (5) ampoules 3ml
KRKA d.d., Novo mesto, Smarjeska
cesta 6, 8501 Novo Mesto
Slovenia
KRKA d.d., Novo mesto, Smarjeska
cesta 6, 8501 Novo Mesto
Slovenia R 16675/1 30.08.2019
15. Co-Diroton
lisinopril (lisinopril dihydrate),
hydrochlorothiazide tablets
20mg+12,5mg; (10/1x10/)
blister, (30/3x10/)
blisters
Gedeon Richter PLC, Gyomroi ut
19-21, 1103 Budapest - batch releaser, Gedeon
Richter Poland Sp.z o.o.,
Hungary
Gedeon Richter PLC, Gyomroi ut
19-21, 1103 Budapest
Hungary R 14403/1 30.08.2019
4
ul.Graniczna 35,Grodzisk
Mazowiecki, 05-825, Poland - bulk
manufacturer, packager
16. Co-Diroton
lisinopril (lisinopril dihydrate),
hydrochlorothiazide tablets
10mg+12,5mg; (10/1x10/)
blister, (30/3x10/)
blisters
Gedeon Richter PLC, Gyomroi ut
19-21, 1103 Budapest - batch releaser, Gedeon
Richter Poland Sp.z o.o.,
ul.Graniczna 35,Grodzisk
Mazowiecki, 05-825, Poland - bulk
manufacturer, packager
Hungary
Gedeon Richter PLC, Gyomroi ut
19-21, 1103 Budapest
Hungary R 14401/1 30.08.2019
17. Detralex diosmin, hesperidin tablets film-
coated
450mg+50mg; (30/2x15/),
(36/3x12/) and (60/4x15/) in
blister
Les Laboratoires Servier Industrie
905, route de Saran, 45520
Gidy
France
Les Laboratoires Servier, 50, rue Carnot, 92284
Suresnes cedex
France OTC 17194/1 30.08.2019
18. Detralex diosmin, hesperidin tablets film-
coated
900mg+100mg; (30/3x10/)
and (60/6x10/) in blister
Les Laboratoires Servier Industrie
905, route de Saran, 45520
Gidy
France
Les Laboratoires Servier, 50, rue Carnot, 92284
Suresnes cedex
France OTC 17509/2 30.08.2019
19. Arixtra
fondaparinux (fondaparinux
sodium)
solution for injection
5mg/ml; (10) pre-filled
syringes 0.5ml
Aspen Notre Dame de
Bondeville, 1 rue de l`Abbaye, 76960 Notre
Dame de Bondeville
France
Aspen Pharma Trading Limited, 3016 Lake Drive,
Citywest Business Campus, Dublin 24
Ireland R 14272/2 30.08.2019
5
20. Nurofen for
children ibuprofen suppositories rectal
60mg; (10/2x5/)
Famar A.V.E., 49km National Road Athens-Lamia, 190 11,
Avlonas
Greece
Reckitt Benckiser Healthcare
International Ltd, Thane Road,
Nottingham, NG90 2DB
UK OTC 15989/1 30.08.2019
21. Denk-Air
Junior 4mg montelukast
(montelukast sodium) tablets chewable 4mg;
(28/2x14/) in blister
Denk Pharma GmbH & Co. KG, Goellstr. 1, 84529
Tittmoning
Germany
Denk Pharma GmbH & Co. KG, Prinzregentenstr.
79, 81675 Muenchen
Germany R 16799/1 30.08.2019
22. Myfortic
mycophenolic acid (mycophenolate
sodium)
tablets gastro-resistant
180mg; (120/12x10/) in
blister
Novartis Pharma Produktions
GmbH, Oeflinger Strasse 44, 79664
Wehr
Germany Novartis Pharma
AG, Lichtstrasse 35, 4056 Basel
Switzerland R 16977/1 30.08.2019
23. Trulicity dulaglutide solution for
injection
0,75mg/0.5ml; (4) pre-filled glass pen
0.5ml
Eli Lilly and Company,
Indianapolis, IN 46285
USA
Eli Lilly and Company,
Indianapolis, IN 46285
USA R 17836/1 30.08.2019
24. Trulicity dulaglutide solution for
injection
1,5mg/0.5ml; (4) pre-filled glass pen
0.5ml
Eli Lilly and Company,
Indianapolis, IN 46285
USA
Eli Lilly and Company,
Indianapolis, IN 46285
USA R 17837/1 30.08.2019
25. Vurdon diclofenac (diclofenac
sodium)
tablets slow release film-
coated
100mg; (10/1x10/), in
blister
Help S.A., Pedini Ioanninon,
Ioannina, 45500 Greece
Help S.A., 10 Valaoritou str., GR
14452 Metamorphosis,
Attica
Greece R 14770/1 30.08.2019
26. Oxolin oxolin ointment nasal
2,5mg/g; 10g aluminium
tube
Nizhpharm JSC, 603950, Nizhny
Novgorod, Salganskaya st., 7
Russia
Nizhpharm JSC, 603950, Nizhny
Novgorod, Salganskaya st., 7
Russia OTC 17033/1 30.08.2019
6
27. Levofloxacin
0.5%
levofloxacin (levofloxacin hemihydrate)
solution for infusion
5mg/ml; 50ml plastic pack, 100ml plastic
pack
PharmaTech CJSC, 0064,
Yerevan, Raffi str. 111
Republic of Armenia
PharmaTech CJSC, 0064, Yerevan,
Raffi str. 111
Republic of Armenia R 14713/1
30.08.2019
28. Pedeks permethrin solution for
external use 5mg/g; 60ml glass bottle
LMP Ltd., 1, Vietalvas street, Riga, LV-1009
Latvia LMP Ltd., 1,
Vietalvas street, Riga, LV-1009
Latvia OTC 15169/1 30.08.2019
29. Mexidol ethylmethylhydroxypy
ridine succinate tablets film-
coated
125mg; (30/3x10/) in
blister, (50/5x10/) in
blister
CJSC "ZiO-Zdorovie",
142103, Moscow region, Podolsk,
str. Zheleznodorozhn
aya, 2
Russia
LLC "RPC "PHARMASOFT",
115407, Moscow,Sudostroitelnaya str., bld. 41,
floor 1, premises 12
Russia R 18448/1 30.08.2019
30. GalvusMET
vildagliptin, metformin (metformin
hydrochloride)
tablets film-coated
50mg+1000mg; (30/3x10/)
and (60/6x10/) in blister
Novartis Pharma Produktions
GmbH, Oeflinger Strasse 44, 79664
Wehr
Germany Novartis Pharma
AG, Lichtstrasse 35, 4056 Basel
Switzerland R 18038/1 30.08.2019
31. Exforge H
amlodipine (amlodipine besilate),
valsartan, hydrochlorothiazide
tablets film-coated
5mg+160mg+12,5mg;
(14/1x14/) and (28/2x14/) in
blister
Novartis Farmaceutica
S.A., Ronda de Santa Maria, 158, 08210 Barbera del Valles, Barcelona
Spain
Novartis Pharma AG, 35,
Lichtstrasse, 4056 Basel
Switzerland R 17440/1 30.08.2019
32. Exforge H
amlodipine (amlodipine besilate),
valsartan, hydrochlorothiazide
tablets film-coated
10mg+160mg+12,5mg;
(14/1x14/) and (28/2x14/) in
blister
Novartis Farmaceutica
S.A., Ronda de Santa Maria, 158, 08210 Barbera del Valles, Barcelona
for
Spain
Novartis Pharma AG, 35,
Lichtstrasse, 4056 Basel
Switzerland R 17441/1 30.08.2019
33. Aclasta zoledronic acid
(zoledronic acid
solution for infusion
0,05mg/ml; 100ml plastic
Novartis Pharma Stein AG,
Schaffhauserstras
Switzerland Novartis Pharma
AG, 35, Lichtstrasse, 4056
Switzerland R 18084/1 30.08.2019
7
monohydrate) vial se, 4332 Stein- batch releaser,
secondary packager,
Fresenius Kabi Austria GmbH,
Hafnerstrasse 36, Graz, 8055, Austria- bulk
manufacturer, primary packager
Basel
34. Bifiform
bifidobacterium longum, enterococcus
faecium
capsules gastro-resistant
not less than 1x10^7CFU+1
x10^7 CFU; (30) and (40) in aluminium
tube
Pfizer Consumer Manufacturing
Italy S.R.L., Via Nettunense, 90, Aprilia, 04011
Italy
Pfizer Innovations LLC, Presnenskaya
nab., building 10, Moscow, 123112
Russia OTC 17374/2 30.08.2019
35. Relium diazepam tablets film-
coated
5mg; (20/1x20/) in
blister
Tarchomin Pharmaceutical Works "Polfa"
S.A., 2,A. Fleminga str.,03-
176 Warsaw
Poland
Tarchomin Pharmaceutical
Works "Polfa" S.A., 2,A. Fleminga
str.,03-176 Warsaw
Poland R 15820/1 30.08.2019
36. Exoderil naftifine (naftifine
hydrochloride) solution for
external use
10mg/ml; 10ml and 20ml glass vial
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl - batch releaser,
Globopharm Pharmazeutische Produktions-und Handels GmbH.,
Breitenfurter Strasse 251, 1230
Wien, Austria- bulk
manufacturer, packager
Austria
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl,
Austria
Austria OTC 17187/1 30.08.2019
8
37. Viagra sildenafil (sildenafil
citrate) tablets film-
coated 25mg; (4/1x4/)
in blister
Fareva Amboise, Zone Industrielle,
29 route des Industries, 37530 Poce-sur-Cisse
France
Pfizer H.C.P. Corporation, 235, East 42nd street New York 10017
USA R 18317/1 30.08.2019
38. Viagra sildenafil (sildenafil
citrate) tablets film-
coated
50mg; (1) blister, (4/1x4/)
blister
Fareva Amboise, Zone Industrielle,
29 route des Industries, 37530 Poce-sur-Cisse
France
Pfizer H.C.P. Corporation, 235, East 42nd street New York 10017
USA R 13918/2 30.08.2019
39. Viagra sildenafil (sildenafil
citrate) tablets film-
coated
100mg; (1) blister, (4/1x4/)
blister
Fareva Amboise, Zone Industrielle,
29 route des Industries, 37530 Poce-sur-Cisse
France
Pfizer H.C.P. Corporation, 235, East 42nd street New York 10017
USA R 13919/2 30.08.2019
40. Azibiot
azithromycin (azithromycin
dihydrate)
tablets film-coated
500mg; (3/1x3/), in
blister
KRKA d.d., Novo mesto, Smarjeska
cesta 6, 8501 Novo Mesto
Slovenia
KRKA d.d., Novo mesto, Smarjeska
cesta 6, 8501 Novo Mesto
Slovenia R 14892/1 30.08.2019
41. Orgalutran ganirelix (ganirelix
acetate) solution for s/c
injection
0,25mg/0,5ml (0,5mg/ml); (5)
pre-filled syringes 0,5ml
N.V. Organon, Molenstraat 110, 5342 CC OSS-
secondary packager, batch releaser (legal address -N.V.
Organon, Kloosterstraat 6,
5349 AB Oss, the Netherlands),
Vetter Pharma-Fertigung GmbH
& Co. KG, Schutzenstrasse
87 and 99/101, D-88212
Ravensburg,
the Netherlands
Schering-Plough Central East AG, Weystrasse 20, 6000 Lucerne 6,
Switzerland R 14458/1 30.08.2019
9
Germany-bulk manufacturer,
primary packager
42. Furadonin nitrofurantoin tablets 50mg; (10), in
strip
Open joint stock company
"Borisovskiy zavod
medicinskikh preparatov" 64, Chapaev str.,
Borisov 222518, Minsk region
Belarus
Open joint stock company
"Borisovskiy zavod medicinskikh
preparatov" 64, Chapaev str.,
Borisov 222518, Minsk region
Belarus R 15524/1 30.08.2019
43. Tyzine
xylometazoline (xylometazoline hydrochloride)
spray nasal
1mg/ml; glass bottle 10ml (70
dose) with dosator
Famar Orleans, 5 avenue de
Concyr, 45071 Orleans, Cedex 2
France
Johnson & Johnson LLC, 121614,
Moscow, Krylatskaya str., 17,
building 2
Russia OTC 18358/1 30.08.2019
44. Tyzine
xylometazoline (xylometazoline hydrochloride)
spray nasal
0,5mg/ml; glass bottle 10ml (140 dose) with
dosator
Famar Orleans, 5 avenue de
Concyr, 45071 Orleans, Cedex 2
for
France
Johnson & Johnson LLC, 121614,
Moscow, Krylatskaya str., 17,
building 2
Russia OTC 18357/1 30.08.2019
45. Co-Amlessa
perindopril (perindopril tert-
butylamine), indapamide, amlodipine
(amlodipine besilate)
tablets 8mg+2,5mg+5mg; (30/3x10/)
in blister
KRKA d.d., Novo mesto, Smarjeska
cesta 6, 8501 Novo Mesto
Slovenia
KRKA d.d., Novo mesto, Smarjeska
cesta 6, 8501 Novo Mesto
Slovenia R 15857/1 30.08.2019
46. Flosteron
betamethasone (betamethasone dipropionate),
betamethasone (betamethasone
sodium phosphate)
suspension for injection
5mg/ml+2mg/ml; (5)
ampoules 1ml
KRKA d.d., Novo mesto, Smarjeska
cesta 6, 8501 Novo Mesto
Slovenia
KRKA d.d., Novo mesto, Smarjeska
cesta 6, 8501 Novo Mesto
Slovenia R 16523/1 30.08.2019
10
47. Puregon follitropin beta
(recombinant) solution for s/c
injection
600IU/0,72ml; cartridge 0,78ml, (6/2x3/) needles
N.V. Organon, Molenstraat 110, 5342 CC OSS-
secondary packager, batch releaser(legal address -N.V.
Organon, Kloosterstraat 6,
5349 AB Oss, the Netherlands)
(Vetter Pharma-Fertigung GmbH
& Co. KG, Mooswiesen 2,
88214 Ravensburg,
Germany-bulk manufacturer,
primary packager)
the Netherlands
Schering-Plough Central East AG, Weystrasse 20,
P.O. Box CH-6000 Lucerne 6
Switzerland R 14512/1 30.08.2019
48. Puregon follitropin beta
(recombinant) solution for s/c
injection
300IU/0,36ml; cartridge 0,42ml, (6/2x3/) needles
N.V. Organon, Molenstraat 110, 5342 CC OSS-
secondary packager, batch releaser(legal address -N.V.
Organon, Kloosterstraat 6,
5349 AB Oss, the Netherlands)
(Vetter Pharma-Fertigung GmbH
& Co. KG, Mooswiesen 2,
88214 Ravensburg,
Germany-bulk manufacturer,
the Netherlands
Schering-Plough Central East AG, Weystrasse 20,
P.O. Box CH-6000 Lucerne 6
Switzerland R 14511/1 30.08.2019
11
primary packager)
49. Tobrex tobramycin drops eye
(solution) 3mg/ml; 5ml plastic vial
S.A. Alcon-Couvreur N.V.,
Rijksweg 14 2870 Puurs
Belgium Novartis Pharma
AG, Lichtstrasse 35, 4056 Basel
Switzerland R 18041/1 30.08.2019
50. Laxalac lactulose solution oral
670mg/ml; glass bottle 100ml and measuring cup, plastic bottle 200ml
and measuring cup, plastic bottle 250ml
and measuring cup
Medical Horizon Ltd, Ararat
province, Masis city, Masis station, Gortsaranain 22
Republic of Armenia
Մեդիկալ Medical Horizon Ltd, Ararat
province, Masis city, Masis station,
Gortsaranain 22
Republic of Armenia OTC 13472/2
30.08.2019
51. Zidin
chlorhexidine (chlorhexidine bigluconate)
suppositories vaginal
16mg; (10/2x5/)
Medical Horizon Ltd, Ararat
province, Masis city, Masis station, Gortsaranain 22
Republic of Armenia
Medical Horizon Ltd, Ararat province,
Masis city, Masis station,
Gortsaranain 22
Republic of Armenia OTC 13319/1
30.08.2019
52. Alotendin
bisoprolol (bisoprolol fumarate), amlodipine (amlodipine besilate)
tablets
5mg+5mg; (28/4x7/) blisters,
(30/3x10/) blisters, (56/8x7/) blisters,
(90/9x10) blisters
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-120
Hungary
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38, Hungary
Hungary R 14046/1 30.08.2019
53. Alotendin
bisoprolol (bisoprolol fumarate), amlodipine (amlodipine besilate)
tablets
5mg+10mg; (28/4x7/) blisters,
(30/3x10/) blisters, (56/8x7/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st.
Hungary
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary R 14047/1 30.08.2019
12
blisters, (90/9x10/)
blisters
118-120 Hungary
54. Alotendin
bisoprolol (bisoprolol fumarate), amlodipine (amlodipine besilate)
tablets
10mg+5mg; (28/4x7/) blisters,
(30/3x10/) blisters, (56/8x7/) blisters,
(90/9x10/) blisters
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-120
Hungary
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38, Hungary
Hungary R 14048/1 30.08.2019
55. Alotendin
bisoprolol (bisoprolol fumarate), amlodipine (amlodipine besilate)
tablets
10mg+10mg; (28/4x7/) blisters,
(30/3x10/) blisters, (56/8x7/) blisters,
(90/9x10/) blisters
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-120
Hungary
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38, Hungary
Hungary R 14049/1 30.08.2019