25
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Annex I
List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the
Member States
Page 2
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Austria
GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, A-1140 Wien AUSTRIA
Zinnat 125 mg/5 ml – Granulat zur
Herstellung einer Suspension zum
Einnehmen
125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
Austria GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, A-1140 Wien AUSTRIA
Zinnat 250 mg - Granulat 250mg Granules Oral use N/A
Austria GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, A-1140 Wien AUSTRIA
Zinnat 250 mg/5 ml – Granulat zur
Herstellung einer Suspension zum
Einnehmen
250mg/5ml Granules for Oral Suspension Oral use 250mg/5ml
Austria GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, A-1140 Wien AUSTRIA
Zinnat 250 mg -Filmtabletten 250mg Film-coated Tablets Oral use N/A
Austria GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, A-1140 Wien AUSTRIA
Zinnat 500 mg -Filmtabletten 500mg Film-coated Tablets Oral use N/A
Belgium
GlaxoSmithKline s.a. / n.v. Rue du Tilleul 13 1332 Genval BELGIUM
Zinnat 250mg/5ml
Granules for Oral Suspension Oral use 250mg/5ml
Belgium
GlaxoSmithKline s.a. / n.v. Rue du Tilleul 13 1332 Genval BELGIUM
Zinnat 250mg Film-coated Tablets Oral use N/A
Page 3
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Belgium
GlaxoSmithKline s.a. / n.v. Rue du Tilleul 13 1332 Genval BELGIUM
Zinnat 500mg Film-coated Tablets Oral use N/A
Bulgaria
GlaxoSmithKline EOOD, Ivan Vazov complex, Dimitar Manov Str., bld 10, 1408 Sofia, BULGARIA
Zinnat 125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
Bulgaria
Glaxo Group Ltd., Greenford road, Greenford, Middlesex, UB6 0NN, UNITED KINGDOM
Zinnat 250mg/5ml Granules for Oral Suspension Oral use 250mg/5ml
Bulgaria
GlaxoSmithKline EOOD, Ivan Vazov complex, Dimitar Manov Str., bld 10, 1408 Sofia, BULGARIA
Zinnat 250mg Film-coated Tablets Oral use N/A
Bulgaria
GlaxoSmithKline EOOD, Ivan Vazov complex, Dimitar Manov Str., bld 10, 1408 Sofia, BULGARIA
Zinnat 500mg Film-coated Tablets Oral use N/A
Cyprus
Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN UNITED KINGDOM
Zinnat 250mg/5ml Granules for Oral Suspension Oral use 250mg/5ml
Cyprus
Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN UNITED KINGDOM
Zinnat 250mg Film-coated Tablets Oral use N/A
Page 4
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Cyprus
Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN UNITED KINGDOM
Zinnat 500mg Film-coated Tablets Oral use N/A
Czech Republic
Glaxo Group Ltd., Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN ENGLAND
Zinnat 125 mg 125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
Czech Republic
Glaxo Group Ltd., Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN ENGLAND
Zinnat 250 mg 250mg/5ml Granules for Oral Suspension Oral use 250mg/5ml
Czech Republic
Glaxo Group Ltd., Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN ENGLAND
Zinnat 125 mg 125mg Film-coated Tablets Oral use N/A
Czech Republic
Glaxo Group Ltd., Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN ENGLAND
Zinnat 250 mg 250mg Film-coated Tablets Oral use N/A
Czech Republic
Glaxo Group Ltd., Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN ENGLAND
Zinnat 500 mg 500mg Film-coated Tablets Oral use N/A
Page 5
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Denmark
GlaxoSmithKline Pharma A/S Nykaer 68, 2605 Broendby DENMARK
Zinnat 125mg/5ml (25mg/ml)
Granules for Oral Suspension Oral use 125mg/5ml
Denmark
GlaxoSmithKline Pharma A/S Nykaer 68, 2605 Broendby DENMARK
Zinnat 125mg Film-coated Tablets Oral use N/A
Denmark
GlaxoSmithKline Pharma A/S Nykaer 68, 2605 Broendby DENMARK
Zinnat 250mg Film-coated Tablets Oral use N/A
Denmark
GlaxoSmithKline Pharma A/S Nykaer 68, 2605 Broendby DENMARK
Zinnat 500mg Film-coated Tablets Oral use N/A
Estonia
Glaxo Group Ltd. Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN UNITED KINGDOM
Zinnat 25mg/1ml Granules for Oral Suspension Oral use 25mg/1ml
Estonia
Glaxo Group Ltd. Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN UNITED KINGDOM
Zinnat 250mg Film-coated Tablet Oral use N/A
Page 6
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Estonia
Glaxo Group Ltd. Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN UNITED KINGDOM
Zinnat 500mg Film-coated Tablet Oral use N/A
Finland GlaxoSmithKline Oy P.O.Box 24 (Piispansilta 9 A), FI-02231 Espoo, FINLAND
Zinnat 50mg/ml Granules for Oral Suspension Oral use N/A
Finland Glaxo Operations UK Ltd, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, UNITED KINGDOM
Zinnat 125mg Film-coated Tablets Oral use N/A
Finland Glaxo Operations UK Ltd, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, UNITED KINGDOM
Zinnat 250mg Film-coated Tablets Oral use N/A
France
Laboratoire GlaxoSmithKline 100, route de Versailles – 78163 Marly-le-Roi Cedex FRANCE
Zinnat 125 mg/5 ml Enfants et
Nourrissons 125mg/5ml Granules for Oral
Suspension Oral use 125mg/5ml
France
Laboratoire GlaxoSmithKline 100, route de Versailles – 78163 Marly-le-Roi Cedex FRANCE
Zinnat 125mg Film-coated Tablets Oral use N/A
France
Laboratoire GlaxoSmithKline 100, route de Versailles – 78163 Marly-le-Roi Cedex FRANCE
Zinnat 250mg Film-coated Tablets Oral use N/A
Page 7
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
France
Laboratoire GlaxoSmithKline 100, route de Versailles – 78163 Marly-le-Roi Cedex FRANCE
Zinnat 500mg Film-coated Tablets Oral use N/A
France
Laboratoire GlaxoSmithKline 100, route de Versailles – 78163 Marly-le-Roi Cedex FRANCE
Zinnat 125 mg Enfants et
Nourrissons 125mg
Granules for Oral Suspension in
sachet Oral use N/A
Germany
GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 80339 München GERMANY
Zinnat -Trockensaft 125mg/5ml (25mg/ml)
Granules for Oral Suspension Oral use 125mg/5ml
Germany
GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 80339 München GERMANY
Zinnat 125mg Film-coated Tablets Oral use N/A
Germany
GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 80339 München GERMANY
Zinnat 250mg Film-coated Tablets Oral use N/A
Germany
GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 80339 München GERMANY
Zinnat 500mg Film-coated Tablets Oral use N/A
Germany
GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 80339 München GERMANY
Elobact 125mg Dosier-Brief 125mg Granules for Oral
Suspension Oral use N/A
Germany
GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 80339 München GERMANY
Elobact Trockensaft 125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
Page 8
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Germany
GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 80339 München GERMANY
Elobact 250mg Dosier-Brief 250mg Granules for Oral
Suspension Oral use N/A
Germany
GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 80339 München GERMANY
Elobact 125mg Film-coated Tablets Oral use N/A
Germany
GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 80339 München GERMANY
Elobact 250mg Film-coated Tablets Oral use N/A
Germany
GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 80339 München GERMANY
Elobact 500mg Film-coated Tablets Oral use N/A
Greece
GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, 152 32 Halandri, Athens GREECE
Zinadol 250mg/5ml Granules for Oral Suspension Oral use 250mg/5ml
Greece
GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, 152 32 Halandri, Athens GREECE
Zinadol 250mg Film-coated Tablets Oral use N/A
Greece
GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, 152 32 Halandri, Athens GREECE
Zinadol 500mg Film-coated Tablets Oral use N/A
Hungary GlaxoSmithKline Kft. 1124 Bp, Csörsz u. 43. HUNGARY
Zinnat 125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
Hungary GlaxoSmithKline Kft. 1124 Bp, Csörsz u. 43. HUNGARY
Zinnat 125mg Film-coated Tablets Oral use N/A
Page 9
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Hungary GlaxoSmithKline Kft. 1124 Bp, Csörsz u. 43. HUNGARY
Zinnat 250mg Film-coated Tablets Oral use N/A
Hungary GlaxoSmithKline Kft. 1124 Bp, Csörsz u. 43. HUNGARY
Zinnat 500mg Film-coated Tablets Oral use N/A
Iceland
GlaxoSmithKline ehf. Thverholt 14 105 Reykjavík. ICELAND
Zinnat 250mg/5ml (25mg/ml)
Granules for Oral Suspension Oral use 250mg/5ml
Iceland
GlaxoSmithKline ehf. Thverholt 14 105 Reykjavík. ICELAND
Zinnat 250mg Film-coated Tablets Oral use N/A
Ireland
GlaxoSmithKline (Ireland) Limited Stonemasons Way, Rathfarnham, Dublin 16 IRELAND
Zinnat 125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
Ireland
GlaxoSmithKline (Ireland) Limited Stonemasons Way, Rathfarnham, Dublin 16 IRELAND
Zinnat 250mg/5ml Granules for Oral Suspension Oral use 250mg/5ml
Ireland
GlaxoSmithKline (Ireland) Limited Stonemasons Way, Rathfarnham, Dublin 16 IRELAND
Zinnat 125mg Film-coated Tablets Oral use N/A
Page 10
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Ireland
GlaxoSmithKline (Ireland) Limited Stonemasons Way, Rathfarnham, Dublin 16 IRELAND
Zinnat 500mg Film-coated Tablets Oral use N/A
Italy
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – 37135 Verona ITALY
Zinnat 125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
Italy
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – 37135 Verona ITALY
Zinnat 250mg Granules for Oral Suspension Oral use N/A
Italy
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – 37135 Verona ITALY
Zinnat 250mg/5ml Granules for Oral Suspension Oral use 250mg/5ml
Italy
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – 37135 Verona ITALY
Zinnat 250mg Film-coated Tablets Oral use N/A
Italy
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – 37135 Verona ITALY
Zinnat 500mg Film-coated Tablets Oral use N/A
Italy
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – 37135 Verona ITALY
Zoref 125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
Italy
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – 37135 Verona ITALY
Zoref 250mg/5ml Granules for Oral Suspension Oral use 250mg/5ml
Page 11
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Italy
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – 37135 Verona ITALY
Zoref 250mg Film-coated Tablets Oral use N/A
Italy
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – 37135 Verona ITALY
Zoref 500mg Film-coated Tablets Oral use N/A
Italy
Malesci Istituto Farmacobiologico S.p.A Via Lungo l’Ema 7, 50012 Bagno A Ripoli Firenze ITALY
Oraxim 125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
Italy
Malesci Istituto Farmacobiologico S.p.A Via Lungo l’Ema 7, 50012 Bagno A Ripoli Firenze ITALY
Oraxim 250 mg Granules for Oral Suspension Oral use N/A
Italy
Malesci Istituto Farmacobiologico S.p.A Via Lungo l’Ema 7, 50012 Bagno A Ripoli Firenze ITALY
Oraxim 125mg/5ml Granules for Oral Suspension Oral use 250mg/5ml
Italy
Malesci Istituto Farmacobiologico S.p.A Via Lungo l’Ema 7, 50012 Bagno A Ripoli Firenze ITALY
Oraxim 250mg Film-coated Tablets Oral use N/A
Page 12
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Italy
Malesci Istituto Farmacobiologico S.p.A Via Lungo l’Ema 7, 50012 Bagno A Ripoli Firenze ITALY
Oraxim 500mg Film-coated Tablets Oral use N/A
Latvia
GlaxoSmithKline Latvia SIA, Bruņinieku 5, Rīga, LV-1001 LATVIA
Zinnat 25 mg/ml granulas iekšķīgi
lietojamas suspensijas
pagatavošanai
125mg/5ml (25mg/ml)
Granules for Oral Suspension Oral use 125mg/5ml
Latvia
GlaxoSmithKline Latvia SIA, Bruņinieku 5, Rīga, LV-1001 LATVIA
Zinnat 250 mg apvalkotās tabletes 250mg Film-coated Tablets Oral use N/A
Latvia
GlaxoSmithKline Latvia SIA,Bruņinieku 5, Rīga, LV-1001 LATVIA
Zinnat 500 mg apvalkotās tabletes 500mg Film-coated Tablets Oral use N/A
Lithuania
UAB „GlaxoSmithKline Lietuva“, A. Goštauto g. 40A, LT-01112 Vilnius, LITHUANIA
Zinnat 125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
Lithuania
UAB „GlaxoSmithKline Lietuva“, A. Goštauto g. 40A, LT-01112 Vilnius, LITHUANIA
Zinnat 125mg Film-coated Tablets Oral use N/A
Lithuania
UAB „GlaxoSmithKline Lietuva“, A. Goštauto g. 40A, LT-01112 Vilnius, LITHUANIA
Zinnat 250mg Film-coated Tablets Oral use N/A
Page 13
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Lithuania
UAB „GlaxoSmithKline Lietuva“, A. Goštauto g. 40A, LT-01112 Vilnius, LITHUANIA
Zinnat 500mg Film-coated Tablets Oral use N/A
Luxembourg
GLAXOSMITHKLINE PHARMACEUTICALS SA 2-4-6, AVENUE PASCAL B-1330 WAVRE
Zinnat 125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
Luxembourg
GLAXOSMITHKLINE PHARMACEUTICALS SA 2-4-6, AVENUE PASCAL B-1330 WAVRE
Zinnat 250mg Granules for Oral Suspension Oral use N/A
Luxembourg
GLAXOSMITHKLINE PHARMACEUTICALS SA 2-4-6, AVENUE PASCAL B-1330 WAVRE
Zinnat 250mg/5ml Granules for Oral Suspension Oral use 250mg/5ml
Luxembourg
GLAXOSMITHKLINE PHARMACEUTICALS SA 2-4-6, AVENUE PASCAL B-1330 WAVRE
Zinnat 125mg Film-coated Tablets Oral use N/A
Luxembourg
/ GLAXOSMITHKLINE PHARMACEUTICALS SA 2-4-6, AVENUE PASCAL B-1330 WAVRE
Zinnat 250mg Film-coated Tablets Oral use N/A
Page 14
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Luxembourg
GLAXOSMITHKLINE PHARMACEUTICALS SA 2-4-6, AVENUE PASCAL B-1330 WAVRE
Zinnat 500mg Film-coated Tablets Oral use N/A
Malta
GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 IRELAND
Zinnat 125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
Malta
GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 IRELAND
Zinnat 250mg/5ml Granules for Oral Suspension Oral use 250mg/5ml
Malta
Glaxo Wellcome UK Limited Glaxo Wellcome House Berkeley avenue Greenford, Middlesex United Kingdom UB6 0NN
Zinnat 250mg Film-coated Tablets Oral use N/A
Malta
GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 IRELAND
Zinnat 500mg Film-coated Tablets Oral use N/A
Netherlands
Glaxo Smith Kline B.V. Huis ter Heideweg 62 3705 LZ ZEIST NETHERLANDS
Zinnat 125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
Netherlands
Glaxo Smith Kline B.V. Huis ter Heideweg 62 3705 LZ ZEIST NETHERLANDS
Zinnat 125mg Film-coated Tablets Oral use N/A
Page 15
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Netherlands
Glaxo Smith Kline B.V. Huis ter Heideweg 62 3705 LZ ZEIST NETHERLANDS
Zinnat 250mg Film-coated Tablets Oral use N/A
Netherlands
Glaxo Smith Kline B.V. Huis ter Heideweg 62 3705 LZ ZEIST NETHERLANDS
Zinnat 500mg Film-coated Tablets Oral use N/A
Poland
GlaxoSmithKline Export Ltd 980 Great West Road Brentford, Middlesex, TW8 9GS UNITED KINGDOM
Zinnat 125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
Poland
GlaxoSmithKline Export Ltd 980 Great West Road Brentford, Middlesex, TW8 9GS UNITED KINGDOM
Zinnat 250mg Granules for Oral Suspension Oral use N/A
Poland
GlaxoSmithKline Export Ltd 980 Great West Road Brentford, Middlesex, TW8 9GS UNITED KINGDOM
Zinnat 250mg/5ml Granules for Oral Suspension Oral use 250mg/5ml
Poland
GlaxoSmithKline Export Ltd 980 Great West Road Brentford, Middlesex, TW8 9GS UNITED KINGDOM
Zinnat 125mg Film-coated Tablets Oral use N/A
Page 16
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Poland
GlaxoSmithKline Export Ltd 980 Great West Road Brentford, Middlesex, TW8 9GS UNITED KINGDOM
Zinnat 250mg Film-coated Tablets Oral use N/A
Poland
GlaxoSmithKline Export Ltd 980 Great West Road Brentford, Middlesex, TW8 9GS UNITED KINGDOM
Zinnat 500mg Film-coated Tablets Oral use N/A
Portugal
Instituto Luso-Fármaco, Lda. Rua Dr António Loureiro Borges nº3 Arquiparque – Miraflores 1495-131 Algés PORTUGAL
Zipos 125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
Portugal
Instituto Luso-Fármaco, Lda. Rua Dr António Loureiro Borges nº3 Arquiparque – Miraflores 1495-131 Algés PORTUGAL
Zipos 250mg/5ml Granules for Oral Suspension Oral use 250mg/5ml
Portugal
Instituto Luso-Fármaco, Lda. Rua Dr António Loureiro Borges nº3 Arquiparque – Miraflores 1495-131 Algés PORTUGAL
Zipos 250mg Film-coated Tablets Oral use N/A
Page 17
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Portugal
Instituto Luso-Fármaco, Lda. Rua Dr António Loureiro Borges nº3 Arquiparque – Miraflores 1495-131 Algés PORTUGAL
Zipos 500mg Film-coated Tablets Oral use N/A
Portugal
GlaxoWellcome Farmacêutica Lda Rua Dr António Loureiro Borges nº3 Arquiparque – Miraflores 1495-131 Algés PORTUGAL
Zoref 125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
Portugal
GlaxoWellcome Farmacêutica Lda Rua Dr António Loureiro Borges nº3 Arquiparque – Miraflores 1495-131 Algés PORTUGAL
Zoref 250mg/5ml Granules for Oral Suspension Oral use 250mg/5ml
Portugal
GlaxoWellcome Farmacêutica Lda Rua Dr António Loureiro Borges nº3 Arquiparque – Miraflores 1495-131 Algés PORTUGAL
Zoref 250mg Film-coated Tablets Oral use N/A
Portugal
GlaxoWellcome Farmacêutica Lda Rua Dr António Loureiro Borges nº3 Arquiparque – Miraflores 1495-131 Algés PORTUGAL
Zoref 500mg Film-coated Tablets Oral use N/A
Page 18
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Romania
Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, UNITED KINGDOM
Zinnat 125mg/5ml Granules for Suspension Oral use 125mg/5ml
Romania
Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, UNITED KINGDOM
Zinnat 125mg Film-coated Tablets Oral use N/A
Romania
Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, UNITED KINGDOM
Zinnat 250mg Film-coated Tablets Oral use N/A
Romania
Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, UNITED KINGDOM
Zinnat 500mg Film-coated Tablets Oral use N/A
Slovakia
GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava Slovak Republic
Zinnat 125 mg/5 ml 125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
Slovakia
GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava Slovak Republic
Zinnat 250 mg/5 ml 250mg/5ml Granules for Oral Suspension Oral use 250mg/5ml
Page 19
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Slovakia
GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava Slovak Republic
Zinnat 125 mg 125mg Film-coated Tablet Oral use N/A
Slovakia
GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava Slovak Republic
Zinnat 250 mg 250mg Film-coated Tablets Oral use N/A
Slovakia
GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava Slovak Republic
Zinnat 500 mg 500mg Film-coated Tablets Oral use N/A
Slovenia
GSK d.o.o., Ljubljana Cvetkova ulica 29 SI-1000 Ljubljana SLOVENIA
Zinnat 125 mg/5 ml zrnca za peroralno
suspenzijo 125mg/5ml Granules for Oral
Suspension Oral use 125mg/5ml
Slovenia
GSK d.o.o., Ljubljana Cvetkova ulica 29 SI-1000 Ljubljana SLOVENIA
Zinnat 250 mg/5 ml zrnca za peroralno
suspenzijo 250mg/5ml Granules for Oral
Suspension Oral use 250mg/5ml
Slovenia
GSK d.o.o., Ljubljana Cvetkova ulica 29 SI-1000 Ljubljana SLOVENIA
Zinnat 250 mg filmsko obložene
tablete 250mg Film-coated Tablets Oral use N/A
Slovenia
GSK d.o.o., Ljubljana Cvetkova ulica 29 SI-1000 Ljubljana SLOVENIA
Zinnat 500 mg filmsko obložene
tablete 500mg Film-coated Tablets Oral use N/A
Spain
GlaxoSmithKline, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
ZINNAT 125 mg granulado para
suspensión oral en sobres
125mg Granules for Oral Suspension Oral use N/A
Page 20
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Spain
GlaxoSmithKline, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
ZINNAT 125 mg/ 5 ml
granulado para suspensión oral en
frasco
125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
Spain
GlaxoSmithKline, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
ZINNAT 250 mg granulado para
suspensión oral en sobres
250mg Granules for Oral Suspension Oral use N/A
Spain
GlaxoSmithKline, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
ZINNAT 250 mg/ 5 ml
granulado para suspensión oral en
frasco
250mg/5ml Granules for Oral Suspension Oral use 250mg/5ml
Spain
GlaxoSmithKline, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
ZINNAT 500 mg granulado para
suspensión oral en sobres
500mg Granules for Oral Suspension Oral use N/A
Spain
GlaxoSmithKline, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
ZINNAT 125 mg comprimidos
recubiertos con película
125mg Film-coated Tablets Oral use N/A
Page 21
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Spain
GlaxoSmithKline, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
ZINNAT 250 mg comprimidos
recubiertos con película
250mg Film-coated Tablets Oral use N/A
Spain
GlaxoSmithKline, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
ZINNAT 500 mg comprimidos
recubiertos con película
500mg Film-coated Tablets Oral use N/A
Spain
GlaxoSmithKline, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
SELAN 125 mg sobres 125mg Granules for Oral
Suspension Oral use N/A
Spain
GlaxoSmithKline, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
SELAN 125 mg suspensión
extemporánea 125mg/5ml Granules for Oral
Suspension Oral use 125mg/5ml
Spain
GlaxoSmithKline, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
SELAN 250 mg suspensión
extemporánea 250mg/5ml Granules for Oral
Suspension Oral use 250mg/5ml
Page 22
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Spain
GlaxoSmithKline, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
SELAN 500 mg sobres 500mg Granules for Oral
Suspension Oral use N/A
Spain
GlaxoSmithKline, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
SELAN 125 mg comprimidos 125mg Film-coated Tablets Oral use N/A
Spain
GlaxoSmithKline, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
SELAN 250 mg comprimidos 250mg Film-coated Tablets Oral use N/A
Spain
GlaxoSmithKline, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
SELAN 500 mg comprimidos 500mg Film-coated Tablets Oral use N/A
Spain
Wellcome Farmacéutica, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
NIVADOR 125 mg/5 ml
granulado para suspensión oral en
frasco
125mg Granules for Oral Suspension Oral use N/A
Page 23
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Spain
Wellcome Farmacéutica, S.A. .- Parque Tecnológico de MadridC/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
NIVADOR 125 mg/5 ml
granulado para suspensión oral en
frasco
125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
Spain
Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
NIVADOR 250 mg granulado para
suspensión oral en sobres
250mg Granules for Oral Suspension Oral use N/A
Spain
Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
NIVADOR 250 mg/5 ml
granulado para suspensión oral en
frasco
250mg/5ml Granules for Oral Suspension Oral use 250mg/5ml
Spain
Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
NIVADOR 500 mg granulado para
suspensión oral en sobres
500mg Granules for Oral Suspension Oral use N/A
Spain
Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
NIVADOR 250 mg comprimidos
recubiertos con película
250mg Film-coated Tablets Oral use N/A
Spain
Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
NIVADOR 500 mg comprimidos
recubiertos con película
500mg Film-coated Tablets Oral use N/A
Page 24
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Spain
Allen Farmacéutica, S.A. Parque Tecnológico de Madrid C/ Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
Cefuroxima Allen 250 mg comprimidos recubiertos con
película EFG
250 mg Film-coated Tablets Oral use N/A
Spain
Allen Farmacéutica, S.A. Parque Tecnológico de Madrid C/ Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
Cefuroxima Allen 500 mg comprimidos recubiertos con
película EFG
500 mg Film-coated Tablets Oral use N/A
Spain
Allen Farmacéutica, S.A. Parque Tecnológico de Madrid C/ Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
Cefuroxima Solasma 250 mg comprimidos
recubiertos con película EFG
250 mg Film-coated Tablets Oral use N/A
Spain
Allen Farmacéutica, S.A. Parque Tecnológico de Madrid C/ Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
Cefuroxima Solasma 500 mg comprimidos
recubiertos con película EFG
500 mg Film-coated Tablets Oral use N/A
Sweden
GlaxoSmithKline AB Box 516 169 29 Solna SWEDEN
Zinnat 25mg/ml
Granules for Oral Suspension Oral use N/A
Page 25
Member State (EU/EEA)
Marketing Authorisation Holder
Invented name Strength Pharmaceutical
Form Route of
administration Content
(concentration)
Sweden
GlaxoSmithKline AB Box 516 169 29 Solna SWEDEN
Zinnat 250mg Film-coated Tablets Oral use N/A
United Kingdom
Glaxo Wellcome UK Ltd, Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Zinnat 125mg/5ml Granules for Oral Suspension Oral use 125mg/5ml
United Kingdom
Glaxo Wellcome UK Ltd, Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Zinnat 250mg/5ml Granules for Oral Suspension Oral use 250mg/5ml
United Kingdom
Glaxo Wellcome UK Ltd, Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Zinnat 125mg Film-coated Tablets Oral use N/A
United Kingdom
Glaxo Wellcome UK Ltd, Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Zinnat 250mg Film-coated Tablets Oral use N/A
United Kingdom
Glaxo Wellcome UK Ltd, Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Zinnat 500mg Film-coated Tablets Oral use N/A
