Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2012 to 31 August 2012 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2012-09-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012293EN.01000901.xml










28.9.2012   


EN


Official Journal of the European Union


C 293/9





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2012 to 31 August 2012

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
 (1)
or Article 38 of Directive 2001/82/EC
 (2)
)

2012/C 293/02
—   Issuing, maintenance or modification of a national marketing authorization










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




23/8/2012


Zinnat and associated names


See Annex


See Annex


27/8/2012






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












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


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




Austria







GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,




A-1140 Wien




AUSTRIA






Zinnat 250 mg – Granulat


250 mg


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


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




Austria







GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,




A-1140 Wien




AUSTRIA






Zinnat 250 mg – Filmtabletten


250 mg


Film-coated Tablets


Oral use


N/A




Austria







GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,




A-1140 Wien




AUSTRIA






Zinnat 500 mg – Filmtabletten


500 mg


Film-coated Tablets


Oral use


N/A




Belgium







GlaxoSmithKline s.a./n.v. Rue du Tilleul 13




1332 Genval




BELGIUM






Zinnat


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




Belgium







GlaxoSmithKline s.a./n.v. Rue du Tilleul 13




1332 Genval




BELGIUM






Zinnat


250 mg


Film-coated Tablets


Oral use


N/A




Belgium







GlaxoSmithKline s.a./n.v. Rue du Tilleul 13




1332 Genval




BELGIUM






Zinnat


500 mg


Film-coated Tablets


Oral use


N/A




Bulgaria


GlaxoSmithKline EOOD, Ivan Vazov complex, Dimitar Manov Str., bld 10, 1408 Sofia, BULGARIA


Zinnat


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




Bulgaria







Glaxo Group Ltd., Greenford road, Greenford, Middlesex, UB6 0NN,




UNITED KINGDOM






Zinnat


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




Bulgaria


GlaxoSmithKline EOOD, Ivan Vazov complex, Dimitar Manov Str., bld 10, 1408 Sofia, BULGARIA


Zinnat


250 mg


Film-coated Tablets


Oral use


N/A




Bulgaria


GlaxoSmithKline EOOD, Ivan Vazov complex, Dimitar Manov Str., bld 10, 1408 Sofia, BULGARIA


Zinnat


500 mg


Film-coated Tablets


Oral use


N/A




Cyprus







Glaxo Group Limited




Berkeley Avenue




Greenford




Middlesex UB6 0NN




UNITED KINGDOM






Zinnat


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




Cyprus







Glaxo Group Limited




Berkeley Avenue




Greenford




Middlesex UB6 0NN




UNITED KINGDOM






Zinnat


250 mg


Film-coated Tablets


Oral use


N/A




Cyprus







Glaxo Group Limited




Berkeley Avenue




Greenford




Middlesex UB6 0NN




UNITED KINGDOM






Zinnat


500 mg


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


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




Czech Republic







Glaxo Group Ltd.,




Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN




ENGLAND






Zinnat 250 mg


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




Czech Republic







Glaxo Group Ltd.,




Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN




ENGLAND






Zinnat 125 mg


125 mg


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


250 mg


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


500 mg


Film-coated Tablets


Oral use


N/A




Denmark







GlaxoSmithKline Pharma A/S




Nykaer 68, 2605 Broendby




DENMARK






Zinnat


125 mg/5 ml (25 mg/ml)


Granules for Oral Suspension


Oral use


125 mg/5 ml




Denmark







GlaxoSmithKline Pharma A/S




Nykaer 68, 2605 Broendby




DENMARK






Zinnat


125 mg


Film-coated Tablets


Oral use


N/A




Denmark







GlaxoSmithKline Pharma A/S




Nykaer 68, 2605 Broendby




DENMARK






Zinnat


250 mg


Film-coated Tablets


Oral use


N/A




Denmark







GlaxoSmithKline Pharma A/S




Nykaer 68, 2605 Broendby




DENMARK






Zinnat


500 mg


Film-coated Tablets


Oral use


N/A




Estonia







Glaxo Group Ltd.




Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN




UNITED KINGDOM






Zinnat


25 mg/1 ml


Granules for Oral Suspension


Oral use


25 mg/1 ml




Estonia







Glaxo Group Ltd.




Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN




UNITED KINGDOM






Zinnat


250 mg


Film-coated Tablet


Oral use


N/A




Estonia







Glaxo Group Ltd.




Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN




UNITED KINGDOM






Zinnat


500 mg


Film-coated Tablet


Oral use


N/A




Finland







GlaxoSmithKline Oy




P.O.Box 24 (Piispansilta 9 A), FI-02231 Espoo, FINLAND






Zinnat


50 mg/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


125 mg


Film-coated Tablets


Oral use


N/A




Finland


Glaxo Operations UK Ltd, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, UNITED KINGDOM


Zinnat


250 mg


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


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




France







Laboratoire GlaxoSmithKline




100, route de Versailles – 78163 Marly-le-Roi Cedex




FRANCE






Zinnat


125 mg


Film-coated Tablets


Oral use


N/A




France







Laboratoire GlaxoSmithKline




100, route de Versailles – 78163 Marly-le-Roi Cedex




FRANCE






Zinnat


250 mg


Film-coated Tablets


Oral use


N/A




France







Laboratoire GlaxoSmithKline




100, route de Versailles – 78163 Marly-le-Roi Cedex




FRANCE






Zinnat


500 mg


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


125 mg


Granules for Oral Suspension in sachet


Oral use


N/A




Germany







GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11




80339 München




GERMANY






Zinnat -Trockensaft


125 mg/5 ml (25 mg/ml)


Granules for Oral Suspension


Oral use


125 mg/5 ml




Germany







GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11




80339 München




GERMANY






Zinnat


125 mg


Film-coated Tablets


Oral use


N/A




Germany







GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11




80339 München




GERMANY






Zinnat


250 mg


Film-coated Tablets


Oral use


N/A




Germany







GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11




80339 München




GERMANY






Zinnat


500 mg


Film-coated Tablets


Oral use


N/A




Germany







GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11




80339 München




GERMANY






Elobact 125 mg Dosier-Brief


125 mg


Granules for Oral Suspension


Oral use


N/A




Germany







GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11




80339 München




GERMANY






Elobact Trockensaft


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




Germany







GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11




80339 München




GERMANY






Elobact 250 mg Dosier-Brief


250 mg


Granules for Oral Suspension


Oral use


N/A




Germany







GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11




80339 München




GERMANY






Elobact


125 mg


Film-coated Tablets


Oral use


N/A




Germany







GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11




80339 München




GERMANY






Elobact


250 mg


Film-coated Tablets


Oral use


N/A




Germany







GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11




80339 München




GERMANY






Elobact


500 mg


Film-coated Tablets


Oral use


N/A




Greece







GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,




152 32 Halandri, Athens




GREECE






Zinadol


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




Greece







GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,




152 32 Halandri, Athens




GREECE






Zinadol


250 mg


Film-coated Tablets


Oral use


N/A




Greece







GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,




152 32 Halandri, Athens




GREECE






Zinadol


500 mg


Film-coated Tablets


Oral use


N/A




Hungary







GlaxoSmithKline Kft.




1124 Bp, Csörsz u. 43.




HUNGARY






Zinnat


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




Hungary







GlaxoSmithKline Kft.




1124 Bp, Csörsz u. 43.




HUNGARY






Zinnat


125 mg


Film-coated Tablets


Oral use


N/A




Hungary







GlaxoSmithKline Kft.




1124 Bp, Csörsz u. 43.




HUNGARY






Zinnat


250 mg


Film-coated Tablets


Oral use


N/A




Hungary







GlaxoSmithKline Kft.




1124 Bp, Csörsz u. 43.




HUNGARY






Zinnat


500 mg


Film-coated Tablets


Oral use


N/A




Iceland







GlaxoSmithKline ehf.




Thverholt 14




105 Reykjavík.




ICELAND






Zinnat


250 mg/5 ml
(25 mg/ml)


Granules for Oral Suspension


Oral use


250 mg/5 ml




Iceland







GlaxoSmithKline ehf.




Thverholt 14




105 Reykjavík.




ICELAND






Zinnat


250 mg


Film-coated Tablets


Oral use


N/A




Ireland







GlaxoSmithKline (Ireland) Limited




Stonemasons Way,




Rathfarnham,




Dublin 16




IRELAND






Zinnat


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




Ireland







GlaxoSmithKline (Ireland) Limited




Stonemasons Way,




Rathfarnham,




Dublin 16




IRELAND






Zinnat


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




Ireland







GlaxoSmithKline (Ireland) Limited




Stonemasons Way,




Rathfarnham,




Dublin 16




IRELAND






Zinnat


125 mg


Film-coated Tablets


Oral use


N/A




Ireland







GlaxoSmithKline (Ireland) Limited




Stonemasons Way,




Rathfarnham,




Dublin 16




IRELAND






Zinnat


500 mg


Film-coated Tablets


Oral use


N/A




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona




ITALY






Zinnat


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona




ITALY






Zinnat


250 mg


Granules for Oral Suspension


Oral use


N/A




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona




ITALY






Zinnat


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona




ITALY






Zinnat


250 mg


Film-coated Tablets


Oral use


N/A




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona




ITALY






Zinnat


500 mg


Film-coated Tablets


Oral use


N/A




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona




ITALY






Zoref


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona




ITALY






Zoref


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona




ITALY






Zoref


250 mg


Film-coated Tablets


Oral use


N/A




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona




ITALY






Zoref


500 mg


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


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




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


125 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




Italy







Malesci Istituto Farmacobiologico S.p.A




Via Lungo l’Ema 7,




50012 Bagno A Ripoli




Firenze




ITALY






Oraxim


250 mg


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


500 mg


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


125 mg/5 ml
(25 mg/ml)


Granules for Oral Suspension


Oral use


125 mg/5 ml




Latvia







GlaxoSmithKline Latvia SIA, Bruņinieku 5, Rīga, LV-1001




LATVIA






Zinnat 250 mg apvalkotās tabletes


250 mg


Film-coated Tablets


Oral use


N/A




Latvia







GlaxoSmithKline Latvia SIA, Bruņinieku 5, Rīga, LV-1001




LATVIA






Zinnat 500 mg apvalkotās tabletes


500 mg


Film-coated Tablets


Oral use


N/A




Lithuania







UAB ‘GlaxoSmithKline Lietuva’,




A. Goštauto g. 40A,




LT-01112 Vilnius, LITHUANIA






Zinnat


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




Lithuania







UAB ‘GlaxoSmithKline Lietuva’,




A. Goštauto g. 40A,




LT-01112 Vilnius, LITHUANIA






Zinnat


125 mg


Film-coated Tablets


Oral use


N/A




Lithuania







UAB ‘GlaxoSmithKline Lietuva’,




A. Goštauto g. 40A,




LT-01112 Vilnius, LITHUANIA






Zinnat


250 mg


Film-coated Tablets


Oral use


N/A




Lithuania







UAB ‘GlaxoSmithKline Lietuva’,




A. Goštauto g. 40A,




LT-01112 Vilnius, LITHUANIA






Zinnat


500 mg


Film-coated Tablets


Oral use


N/A




Luxembourg







GLAXOSMITHKLINE PHARMACEUTICALS SA




2-4-6, AVENUE PASCAL B-1330 WAVRE






Zinnat


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




Luxembourg







GLAXOSMITHKLINE PHARMACEUTICALS SA




2-4-6, AVENUE PASCAL B-1330 WAVRE






Zinnat


250 mg


Granules for Oral Suspension


Oral use


N/A




Luxembourg







GLAXOSMITHKLINE PHARMACEUTICALS SA




2-4-6, AVENUE PASCAL B-1330 WAVRE






Zinnat


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




Luxembourg







GLAXOSMITHKLINE PHARMACEUTICALS SA




2-4-6, AVENUE PASCAL B-1330 WAVRE






Zinnat


125 mg


Film-coated Tablets


Oral use


N/A




Luxembourg







GLAXOSMITHKLINE PHARMACEUTICALS SA




2-4-6, AVENUE PASCAL B-1330 WAVRE






Zinnat


250 mg


Film-coated Tablets


Oral use


N/A




Luxembourg







GLAXOSMITHKLINE PHARMACEUTICALS SA




2-4-6, AVENUE PASCAL B-1330 WAVRE






Zinnat


500 mg


Film-coated Tablets


Oral use


N/A




Malta


GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 IRELAND


Zinnat


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




Malta


GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 IRELAND


Zinnat


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




Malta







Glaxo Wellcome UK Limited




Glaxo Wellcome House




Berkeley avenue




Greenford, Middlesex




United Kingdom




UB6 0NN






Zinnat


250 mg


Film-coated Tablets


Oral use


N/A




Malta


GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 IRELAND


Zinnat


500 mg


Film-coated Tablets


Oral use


N/A




Netherlands







Glaxo Smith Kline B.V.




Huis ter Heideweg 62




3705 LZ ZEIST




NETHERLANDS






Zinnat


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




Netherlands







Glaxo Smith Kline B.V.




Huis ter Heideweg 62




3705 LZ ZEIST




NETHERLANDS






Zinnat


125 mg


Film-coated Tablets


Oral use


N/A




Netherlands







Glaxo Smith Kline B.V.




Huis ter Heideweg 62




3705 LZ ZEIST




NETHERLANDS






Zinnat


250 mg


Film-coated Tablets


Oral use


N/A




Netherlands







Glaxo Smith Kline B.V.




Huis ter Heideweg 62




3705 LZ ZEIST




NETHERLANDS






Zinnat


500 mg


Film-coated Tablets


Oral use


N/A




Poland







GlaxoSmithKline Export Ltd




980 Great West Road




Brentford, Middlesex, TW8 9GS




UNITED KINGDOM






Zinnat


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




Poland







GlaxoSmithKline Export Ltd




980 Great West Road




Brentford, Middlesex, TW8 9GS




UNITED KINGDOM






Zinnat


250 mg


Granules for Oral Suspension


Oral use


N/A




Poland







GlaxoSmithKline Export Ltd




980 Great West Road




Brentford, Middlesex, TW8 9GS




UNITED KINGDOM






Zinnat


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




Poland







GlaxoSmithKline Export Ltd




980 Great West Road




Brentford, Middlesex, TW8 9GS




UNITED KINGDOM






Zinnat


125 mg


Film-coated Tablets


Oral use


N/A




Poland







GlaxoSmithKline Export Ltd




980 Great West Road




Brentford, Middlesex, TW8 9GS




UNITED KINGDOM






Zinnat


250 mg


Film-coated Tablets


Oral use


N/A




Poland







GlaxoSmithKline Export Ltd




980 Great West Road




Brentford, Middlesex, TW8 9GS




UNITED KINGDOM






Zinnat


500 mg


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


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




Portugal







Instituto Luso-Fármaco, Lda.




Rua Dr António Loureiro Borges no3




Arquiparque – Miraflores




1495-131 Algés




PORTUGAL






Zipos


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




Portugal







Instituto Luso-Fármaco, Lda.




Rua Dr António Loureiro Borges no3




Arquiparque – Miraflores




1495-131 Algés




PORTUGAL






Zipos


250 mg


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


500 mg


Film-coated Tablets


Oral use


N/A




Portugal







GlaxoWellcome Farmacêutica Lda




Rua Dr António Loureiro Borges no3




Arquiparque – Miraflores




1495-131 Algés




PORTUGAL






Zoref


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




Portugal







GlaxoWellcome Farmacêutica Lda




Rua Dr António Loureiro Borges no3




Arquiparque – Miraflores




1495-131 Algés




PORTUGAL






Zoref


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




Portugal







GlaxoWellcome Farmacêutica Lda




Rua Dr António Loureiro Borges no3




Arquiparque – Miraflores




1495-131 Algés




PORTUGAL






Zoref


250 mg


Film-coated Tablets


Oral use


N/A




Portugal







GlaxoWellcome Farmacêutica Lda




Rua Dr António Loureiro Borges no3




Arquiparque – Miraflores




1495-131 Algés




PORTUGAL






Zoref


500 mg


Film-coated Tablets


Oral use


N/A




Romania







Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN,




UNITED KINGDOM






Zinnat


125 mg/5 ml


Granules for Suspension


Oral use


125 mg/5 ml




Romania







Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN,




UNITED KINGDOM






Zinnat


125 mg


Film-coated Tablets


Oral use


N/A




Romania







Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN,




UNITED KINGDOM






Zinnat


250 mg


Film-coated Tablets


Oral use


N/A




Romania







Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN,




UNITED KINGDOM






Zinnat


500 mg


Film-coated Tablets


Oral use


N/A




Slovakia







GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava




Slovak Republic






Zinnat 125 mg/5 ml


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




Slovakia







GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava




Slovak Republic






Zinnat 250 mg/5 ml


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




Slovakia







GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava




Slovak Republic






Zinnat 125 mg


125 mg


Film-coated Tablet


Oral use


N/A




Slovakia







GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava




Slovak Republic






Zinnat 250 mg


250 mg


Film-coated Tablets


Oral use


N/A




Slovakia







GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava




Slovak Republic






Zinnat 500 mg


500 mg


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


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




Slovenia







GSK d.o.o., Ljubljana




Cvetkova ulica 29




SI-1000 Ljubljana




SLOVENIA






Zinnat 250 mg/5 ml zrnca za peroralno suspenzijo


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




Slovenia







GSK d.o.o., Ljubljana




Cvetkova ulica 29




SI-1000 Ljubljana




SLOVENIA






Zinnat 250 mg filmsko obložene tablete


250 mg


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


500 mg


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


125 mg


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/5 ml granulado para suspensión oral en frasco


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




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


250 mg


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


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




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


500 mg


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


125 mg


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 250 mg comprimidos recubiertos con película


250 mg


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


500 mg


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


125 mg


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


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




Spain







GlaxoSmithKline, S.A.




Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)




SPAIN






SELAN 250 mg suspensión extemporánea


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




Spain







GlaxoSmithKline, S.A.




Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)




SPAIN






SELAN 500 mg sobres


500 mg


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


125 mg


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


250 mg


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


500 mg


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


125 mg


Granules for Oral Suspension


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


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




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


250 mg


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


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




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


500 mg


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


250 mg


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


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 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


25 mg/ml


Granules for Oral Suspension


Oral use


N/A




Sweden







GlaxoSmithKline AB




Box 516




169 29 Solna




SWEDEN






Zinnat


250 mg


Film-coated Tablets


Oral use


N/A




United Kingdom







Glaxo Wellcome UK Ltd,




Stockley Park West, Uxbridge, Middlesex, UB11 1BT






Zinnat


125 mg/5 ml


Granules for Oral Suspension


Oral use


125 mg/5 ml




United Kingdom







Glaxo Wellcome UK Ltd,




Stockley Park West, Uxbridge, Middlesex, UB11 1BT






Zinnat


250 mg/5 ml


Granules for Oral Suspension


Oral use


250 mg/5 ml




United Kingdom







Glaxo Wellcome UK Ltd,




Stockley Park West, Uxbridge, Middlesex, UB11 1BT






Zinnat


125 mg


Film-coated Tablets


Oral use


N/A




United Kingdom







Glaxo Wellcome UK Ltd,




Stockley Park West, Uxbridge, Middlesex, UB11 1BT






Zinnat


250 mg


Film-coated Tablets


Oral use


N/A




United Kingdom







Glaxo Wellcome UK Ltd,




Stockley Park West, Uxbridge, Middlesex, UB11 1BT






Zinnat


500 mg


Film-coated Tablets


Oral use


N/A