EN Official Journal of the European Union C 328/8

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2012 to 30 September 2012

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

2012/C 328/02

— 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 17.9.2012 Nuflor 300 mg/ml See Annex I See Annex I 18.9.2012 28.9.2012 Yvidually and associated names See Annex II See Annex II 3.10.2012 11.9.2012 Mifepristone Linepharma and associated names See Annex III See Annex III 13.9.2012 10.9.2012 Zinacef and associated names See Annex IV See Annex IV 11.9.2012 3.9.2012 Trimetazidine See Annex V See Annex V 4.9.2012

(1) OJ L 311, 28.11.2001, p. 67.

(2) OJ L 311, 28.11.2001, p. 1.

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES Member State EU/EEA Applicant Name Pharmaceutical form Strength Animal species Route of administration Belgium Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor 300 mg/ml solution for injection for cattle and sheep Solution for injection 300 mg/ml Cattle and sheep Cattle – subcutaneous and intramuscular Sheep – intramuscular Denmark Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor 300 mg/ml solution for injection for cattle and sheep Solution for injection 300 mg/ml Cattle and sheep Cattle – subcutaneous and intramuscular Sheep – intramuscular France Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor 300 mg/ml solution for injection for cattle and sheep Solution for injection 300 mg/ml Cattle and sheep Cattle – subcutaneous and intramuscular Sheep – intramuscular Germany Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor 300 mg/ml solution for injection for cattle and sheep Solution for injection 300 mg/ml Cattle and sheep Cattle – subcutaneous and intramuscular Sheep – intramuscular Greece Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor 300 mg/ml solution for injection for cattle and sheep Solution for injection 300 mg/ml Cattle and sheep Cattle – subcutaneous and intramuscular Sheep – intramuscular Ireland Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor 300 mg/ml solution for injection for cattle and sheep Solution for injection 300 mg/ml Cattle and sheep Cattle – subcutaneous and intramuscular Sheep – intramuscular Italy Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor 300 mg/ml solution for injection for cattle and sheep Solution for injection 300 mg/ml Cattle and sheep Cattle – subcutaneous and intramuscular Sheep – intramuscular Luxembourg Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor 300 mg/ml solution for injection for cattle and sheep Solution for injection 300 mg/ml Cattle and sheep Cattle – subcutaneous and intramuscular Sheep – intramuscular The Netherlands Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor 300 mg/ml solution for injection for cattle and sheep Solution for injection 300 mg/ml Cattle and sheep Cattle – subcutaneous and intramuscular Sheep – intramuscular Portugal Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor 300 mg/ml solution for injection for cattle and sheep Solution for injection 300 mg/ml Cattle and sheep Cattle – subcutaneous and intramuscular Sheep – intramuscular Spain Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor 300 mg/ml solution for injection for cattle and sheep Solution for injection 300 mg/ml Cattle and sheep Cattle – subcutaneous and intramuscular Sheep – intramuscular United Kingdom Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor 300 mg/ml solution for injection for cattle and sheep Solution for injection 300 mg/ml Cattle and sheep Cattle – subcutaneous and intramuscular Sheep – intramuscular

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES Member State EU/EEA Applicant Invented Name Strength Pharmaceutical form Route of administration Austria Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Delivrie 0,02 mg/3 mg Filmtabletten ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Belgium Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Yvidually ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Bulgaria Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Flexyess ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Cyprus Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Flexyess ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Czech Republic Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Flexyess ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Denmark Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Delivrie ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Estonia Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Yvidually ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Finland Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Flexyess ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use France Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Flexyess ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Germany Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Flexyess ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Greece Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Flexyess ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Hungary Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Flexyess ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Iceland Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Delivrie ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Ireland Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Delivrie ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Italy Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Yvidually ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Latvia Bayer Pharma AG Müllerstrasse 170-178 D-13353, Berlin Germany Yvidually 0,02 mg/3 mg apvalkotās tabletes ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Lithuania Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Flexyess ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Luxembourg Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Delivrie ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Malta Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Flexyess ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use The Netherlands Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Yvidually ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Norway Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Flexyess ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Poland Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Flexyess ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Portugal Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Flexyess ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Romania Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Yvidually ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Slovak Republic Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Flexyess ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Slovenia Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Flexyess ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Spain Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Delivrie ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use Sweden Bayer B.V. Energieweg 1, 3641 RT Mijdrecht the Netherlands Delivrie ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use United Kingdom Bayer plc, Bayer House Strawberry Hill Newbury, Berkshire RG14 1JA United Kingdom Delivrie ethinylestradiol: 0.02 mg Drospirenone: 3 mg film-coated tablet Oral use

ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder Applicant Name Strength Pharmaceutical form Route of administration Denmark Linepharma France, 140 bis rue de Rennes 75006 Paris France Mifepriston Linepharma 200 mg Tablet Oral use Finland Linepharma France, 140 bis rue de Rennes 75006 Paris France Mifepristone Linepharma 200 mg Tablet Oral use France Linepharma France, 140 bis rue de Rennes 75006 Paris France Mifepristone Linepharma 200 mg comprimé 200 mg Tablet Oral use Iceland Linepharma France, 140 bis rue de Rennes 75006 Paris France Mifepristone Linepharma 200 mg Tafla 200 mg Tablet Oral use Norway Linepharma France, 140 bis rue de Rennes 75006 Paris France Mifepristone Linepharma 200 mg Tablet Oral use Sweden Linepharma France, 140 bis rue de Rennes 75006 Paris France Mifepristone Linepharma 200 mg Tablet Oral use United Kingdom Linepharma France, 140 bis rue de Rennes 75006 Paris France Mifepristone Linepharma 200 mg tablet 200 mg Tablet Oral use

ANNEX IV LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES 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 Curocef 1 500 mg - Trockenstechampullen 1,5 g Powder for Injection or Infusion Intravenous Use Injection: 1,5 g/15 ml Infusion: 1,5 g/15 ml + 50 ml or 100 ml Austria GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, A-1140 Wien AUSTRIA Curocef 1 500 mg - Trockensubstanz zur Infusionsbereitung 1,5 g Powder for Infusion Intravenous Use 1,5 g/15 ml + 50 ml or 100 ml Austria GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, A-1140 Wien AUSTRIA Curocef 250 mg - Trockenstechamupllen 250 mg Powder for Injection Intramuscular Use or Intravenous Use 250 mg/1 ml or 250 mg/2-5 ml Austria GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, A-1140 Wien AUSTRIA Curocef 750 mg - Trockenstechampullen 750 mg Powder for Injection Intramuscular Use or Intravenous Use 750 mg/3 ml or 750 mg/6-10 ml Belgium GlaxoSmithKline s.a./n.v. Rue du Tilleul 13 1332 Genval BELGIUM Zinacef 1,5 g Powder for Solution for Infusion Intravenous Use 1,5 g 50 ml Belgium GlaxoSmithKline s.a./n.v. Rue du Tilleul 13 1332 Genval BELGIUM Zinacef 1,5 g Powder for Solution for Injection Intravenous Use 1,5 g 15 ml Belgium GlaxoSmithKline s.a./n.v. Rue du Tilleul 13 1332 Genval BELGIUM Zinacef 750 mg Powder for Solution for Injection Intravenous Use 750 mg 6 ml Bulgaria Glaxo Group Ltd., Greenford, Middlesex UB6 0NN UNITED KINGDOM Zinacef 1,5 g Powder for Solution for Injection Intravenous Use 1,5 g 15 ml Bulgaria Glaxo Group Ltd., Greenford, Middlesex UB6 0NN UNITED KINGDOM Zinacef 750 mg Powder for Solution for Injection Intravenous Use 750 mg 6 ml Bulgaria Glaxo Group Ltd., Greenford, Middlesex UB6 0NN UNITED KINGDOM Zinacef 750 mg Powder for Solution for Injection Intramuscular Use 750 mg 3 ml Cyprus Glaxo Group Limited Berkeley Avenue Greenford Middlex UB6 0NN UNITED KINGDOM Zinacef 1,5 g Powder for Infusion Intravenous Use 1,5 g 50 ml Cyprus Glaxo Group Limited Berkeley Avenue Greenford Middlex UB6 0NN UNITED KINGDOM Zinacef 1,5 g Powder for Injection Intravenous Use 1,5 g 15 ml Cyprus Glaxo Group Limited Berkeley Avenue Greenford Middlex UB6 0NN UNITED KINGDOM Zinacef 750 mg Powder for Infusion Intravenous Use 750 mg 6 ml Cyprus Glaxo Group Limited Berkeley Avenue Greenford Middlex UB6 0NN UNITED KINGDOM Zinacef 750 mg Powder for Injection Intramuscular Use 750 mg 3 ml Czech Republic Glaxo Group Ltd., Glaxo Welcome House, Berkeley avenue, Greenford, Middlesex UB6 0NN ENGLAND Zinacef 1,5 g 1,5 g Powder for Injection Intravenous Use 1,5 g 50 ml Czech Republic Glaxo Group Ltd., Glaxo Welcome House, Berkeley avenue, Greenford, Middlesex UB6 0NN ENGLAND Zinacef 1,5 g 1,5 g Powder for Injection Intravenous Use 1,5 g 15 ml Czech Republic Glaxo Group Ltd., Glaxo Welcome House, Berkeley avenue, Greenford, Middlesex UB6 0NN ENGLAND Zinacef 750 mg 750 mg Powder for Injection Intramuscular Use 750 mg 3 ml Czech Republic Glaxo Group Ltd., Glaxo Welcome House, Berkeley avenue, Greenford, Middlesex UB6 0NN ENGLAND Zinacef 750 mg 750 mg Powder for Injection Intravenous Use 750 mg 6 ml Denmark GlaxoSmithKline Pharma A/S Nykaer 68, 2605 Broendby DENMARK Zinacef 1,5 g Powder for Solution for Infusion Intravenous Use 1,5 g 50 ml Denmark GlaxoSmithKline Pharma A/S Nykaer 68, 2605 Broendby DENMARK Zinacef 1,5 g Powder for Solution for Injection Intravenous Use 1,5 g 15 ml Denmark GlaxoSmithKline Pharma A/S Nykaer 68, 2605 Broendby DENMARK Zinacef 250 mg Powder for Solution for Injection Intramuscular Use 250 mg 1 ml Denmark GlaxoSmithKline Pharma A/S Nykaer 68, 2605 Broendby DENMARK Zinacef 250 mg Powder for Solution for Injection Intravenous Use 250 mg 2 ml Denmark GlaxoSmithKline Pharma A/S Nykaer 68, 2605 Broendby DENMARK Zinacef 750 mg Powder for Solution for Infusion Intramuscular Use 750 mg 3 ml Denmark GlaxoSmithKline Pharma A/S Nykaer 68, 2605 Broendby DENMARK Zinacef 750 mg Powder for Solution for Injection Intravenous Use 750 mg 6 ml Estonia Glaxo Group Ltd, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN UNITED KINGDOM Zinacef 1,5 g Powder for solution for injection Intravenous use, intramuscular use 1,5 g Estonia Glaxo Group Ltd, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN UNITED KINGDOM Zinacef 750 mg Powder for solution for injection Intravenous use, intramuscular use 750 mg Finland GlaxoSmithKline Oy P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND Zinacef 1,5 g Powder for solution/suspension for injection/infusion Intravenous Use 1,5 g/15 ml Finland GlaxoSmithKline Oy P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND Zinacef 1,5 g Powder for solution/suspension for injection/infusion Intravenous Use 1,5 g/50-100 ml Finland GlaxoSmithKline Oy P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND Zinacef 250 mg Powder for solution/suspension for injection Intramuscular Use 250 mg/2 ml Finland GlaxoSmithKline Oy P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND Zinacef 250 mg Powder for solution/suspension for injection/infusion Intravenous Use 250 mg/2 ml Finland GlaxoSmithKline Oy P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND Zinacef 750 mg Powder for solution/suspension for injection Intramuscular Use 750 mg/3 ml Finland GlaxoSmithKline Oy P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND Zinacef 750 mg Powder for solution/suspension for injection Intravenous Use 750 mg/6 ml France Laboratoire GlaxoSmithKline 100, route de Versailles – 78163 Marly-le-Roi Cedex FRANCE Zinnat 1,5 g Powder for solution for Infusion Intravenous Use 1,5 g 50 ml France Laboratoire GlaxoSmithKline 100, route de Versailles – 78163 Marly-le-Roi Cedex FRANCE Zinnat 250 mg Powder for solution for Injection Intravenous Use and Intramuscular use (Only one MA for 250 mg strength) 250 mg France Laboratoire GlaxoSmithKline 100, route de Versailles – 78163 Marly-le-Roi Cedex FRANCE Zinnat 750 mg Powder and solvent for suspension for Injection Intramuscular Use 750 mg France Laboratoire GlaxoSmithKline 100, route de Versailles – 78163 Marly-le-Roi Cedex FRANCE Zinnat 750 mg Powder for solution for Injection Intravenous Use and Intramuscular use 750 mg Greece GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, 152 32 Halandri, Athens GREECE Zinacef 1,5 g Powder for Infusion Intravenous Use 1,5 g/VIAL Greece GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, 152 32 Halandri, Athens GREECE Zinacef 250 mg Powder for Injection Intravenous Use Intramuscular Use 250 mg/VIAL Greece GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, 152 32 Halandri, Athens GREECE Zinacef 750 mg Powder for Injection Intravenous Use Intramuscular Use 750 mg/VIAL Hungary GlaxoSmithKline Kft. 1124 Bp, Csörsz u. 43. HUNGARY Zinacef 1,5 g Powder for Injection Intravenous Use 1,5 g Hungary GlaxoSmithKline Kft. 1124 Bp, Csörsz u. 43. HUNGARY Zinacef 250 mg Solution for injection Intravenous Use 250 mg + 1 x 2 ml solvent Hungary GlaxoSmithKline Kft. 1124 Bp, Csörsz u. 43. HUNGARY Zinacef 250 mg Powder for Injection Intramuscular Use 250 mg Hungary GlaxoSmithKline Kft. 1124 Bp, Csörsz u. 43. HUNGARY Zinacef 750 mg Solution for injection Intravenous Use 750 mg + 1 x 6 ml solvent Hungary GlaxoSmithKline Kft. 1124 Bp, Csörsz u. 43. HUNGARY Zinacef 750 mg Powder for Injection Intramuscular Use 750 mg Iceland GlaxoSmithKline ehf. Thverholt 14 105 Reykjavík. ICELAND Zinacef 1,5 g Powder for Infusion Intravenous Use 1,5 g 50 ml Iceland GlaxoSmithKline ehf. Thverholt 14 105 Reykjavík. ICELAND Zinacef 1,5 g Powder for Injection Intravenous Use 1,5 g 15 ml Iceland GlaxoSmithKline ehf. Thverholt 14 105 Reykjavík. ICELAND Zinacef 750 mg Powder for Infusion Intramuscular Use 750 mg 3 ml Iceland GlaxoSmithKline ehf. Thverholt 14 105 Reykjavík. ICELAND Zinacef 750 mg Powder for Injection Intravenous Use 750 mg 6 ml Ireland GlaxoSmithKline (Ireland) Limited Stonemasons Way, Rathfarnham, Dublin 16 IRELAND Zinacef 1,5 g Powder for injection or solution for infusion Intravenous Use 1,5 g Ireland GlaxoSmithKline (Ireland) Limited Stonemasons Way, Rathfarnham, Dublin 16 IRELAND Zinacef 250 mg Powder for solution or suspension for injection Intravenous or Intramuscular Use 250 mg Ireland GlaxoSmithKline (Ireland) Limited Stonemasons Way, Rathfarnham, Dublin 16 IRELAND Zinacef 750 mg Powder for solution for injection Intravenous or IntramuscularUse 750 mg Italy GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – 37135 Verona ITALY Curoxim 250 mg Powder and solvent for suspension for Injection Intramuscular Use 250 mg/ml Italy GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – 37135 Verona ITALY Curoxim 500 mg Powder and solvent for suspension for Injection Intramuscular Use 500 mg/2 ml Italy GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – 37135 Verona ITALY Curoxim 750 mg Powder and solvent for suspension for Injection Intramuscular Use 750 mg/3 ml Italy GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – 37135 Verona ITALY Curoxim 1 g Powder and solvent for suspension for Injection Intravenous Use 1 g/10 ml Italy GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – 37135 Verona ITALY Curoxim 1 g Powder and solvent for suspension for Injection Intramuscular Use 1 g/4 ml Italy GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – 37135 Verona ITALY Curoxim 2 g Powder for solution for Infusion Intravenous Use 2 g Italy GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – 37135 Verona ITALY Curoxim 1,5 g Powder for solution for Infusion Intravenous Use 1,5 g Italy GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – 37135 Verona ITALY Curoxim 750 mg Powder for solution for Infusion Intravenous Use 750 mg Lithuania Glaxo Operations UK Limited, Greenford, Middlesex, UB6 0HE, UNITED KINGDOM Zinacef 1,5 g Powder for Injection Intravenous Use/Intramuscular Use Lithuania Glaxo Operations UK Limited, Greenford, Middlesex, UB6 0HE, UNITED KINGDOM Zinacef 250 mg Powder and Solvant for Solution for Injection Intravenous Us/Intramuscular Use Lithuania Glaxo Operations UK Limited, Greenford, Middlesex, UB6 0HE, UNITED KINGDOM Zinacef 750 mg Powder and Solvant for Solution for Injection Intravenous Use/Intramuscular Use Luxembourg GLAXOSMITHKLINE PHARMACEUTICALS SA 2-4-6, AVENUE PASCAL B-1330 WAVRE Zinacef 1,5 g Powder for Solution for Infusion Intravenous Use 1,5 g 50 ml Luxembourg GLAXOSMITHKLINE PHARMACEUTICALS SA 2-4-6, AVENUE PASCAL B-1330 WAVRE Zinacef 1,5 g Powder for Solution for Injection Intravenous Use 1,5 g 15 ml Luxembourg GLAXOSMITHKLINE PHARMACEUTICALS SA 2-4-6, AVENUE PASCAL B-1330 WAVRE Zinacef 750 mg Powder for Solution for Injection Intravenous Use 750 mg 6 ml Luxembourg GLAXOSMITHKLINE PHARMACEUTICALS SA 2-4-6, AVENUE PASCAL B-1330 WAVRE Zinacef 750 mg Powder for Solution for Infusion Intravenous Use 750 mg 50 ml Luxembourg GLAXOSMITHKLINE PHARMACEUTICALS SA 2-4-6, AVENUE PASCAL B-1330 WAVRE Zinacef 750 mg Powder for Solution for Injection Intramuscular Use 750 mg 3 ml Malta Glaxo Operations UK Limited Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 0HE UNITED KINGDOM Zinacef 250 mg Powder for suspension for Injection Intravenous Use 250 mg 2 ml Malta Glaxo Operations UK Limited Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 0HE UNITED KINGDOM Zinacef 250 mg Powder for suspension for Injection Intramuscular Use 250 mg 1 ml Malta Glaxo Operations UK Limited Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 0HE UNITED KINGDOM Zinacef 750 mg Powder for suspension for Injection Intravenous Use 750 mg 6 ml Malta Glaxo Operations UK Limited Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 0HE UNITED KINGDOM Zinacef 750 mg Powder for suspension for Injection Intramuscular Use 750 mg 3 ml Netherlands Glaxo Smith Kline B.V. Huis ter Heideweg 62 3705 LZ ZEIST NETHERLANDS Zinacef 1,5 g Powder for suspension for Injection Intravenous Use 1,5 g 15 ml Netherlands Glaxo Smith Kline B.V. Huis ter Heideweg 62 3705 LZ ZEIST NETHERLANDS Zinacef 1,5 g Powder for suspension for Infusion Intravenous Use 1,5 g 100 ml Netherlands Glaxo Smith Kline B.V. Huis ter Heideweg 62 3705 LZ ZEIST NETHERLANDS Zinacef 250 mg Powder for suspension for Injection Intravenous Use Intrarmuscular Use 250 mg 2 ml (intravenous) 250 mg 1 ml (intramuscular) Netherlands Glaxo Smith Kline B.V. Huis ter Heideweg 62 3705 LZ ZEIST NETHERLANDS Zinacef 750 mg Powder for suspension for Injection Intravenous Use Intrarmuscular Use 750 mg 6 ml (intravenous) 750 mg 3 ml (intramuscular) Norway GlaxoSmithKline AS Forskningsveien 2A Postboks 180 Vinderen 0319 Oslo NORWAY Zinacef 1,5 g Powder for Infusion Intravenous Use 1,5 g 50 ml Norway GlaxoSmithKline AS Forskningsveien 2A Postboks 180 Vinderen 0319 Oslo NORWAY Zinacef 1,5 g Powder for Injection Intravenous Use 1,5 g 15 ml Norway GlaxoSmithKline AS Forskningsveien 2A Postboks 180 Vinderen 0319 Oslo NORWAY Zinacef 250 mg Powder for Injection Intermuscular Use 250 mg 1 ml Norway GlaxoSmithKline AS Forskningsveien 2A Postboks 180 Vinderen 0319 Oslo NORWAY Zinacef 250 mg Powder for Injection Intravenous Use 250 mg 2 ml Norway GlaxoSmithKline AS Forskningsveien 2A Postboks 180 Vinderen 0319 Oslo NORWAY Zinacef 750 mg Powder for Injection Intravenous Use 750 mg 6 ml Norway GlaxoSmithKline AS Forskningsveien 2A Postboks 180 Vinderen 0319 Oslo NORWAY Zinacef 750 mg Powder for Injection Intermuscular Use 750 mg 3 ml Poland GlaxoSmithKline Export Ltd. 980 Great West Road Brentford, Middlesex, TW8 9GS UNITED KINGDOM Zinacef 1,5 g Powder for solution for injection and infusion Intravenous Use 1,5 g/15 ml 1,5 g/50-100 ml 1,5 g (Monovial) Poland GlaxoSmithKline Export Ltd. 980 Great West Road Brentford, Middlesex, TW8 9GS UNITED KINGDOM Zinacef 750 mg Powder for suspension for injection or solution for injection and infusion Intramuscular Use, Intravenous Use 750 mg/3 ml IM 750 mg/6 ml IV 750 mg IV (Monovial) Portugal GlaxoWellcome Farmacêutica Lda Rua Dr António Loureiro Borges no3 Arquiparque – Miraflores 1495-131 Algés PORTUGAL Curoxime 750 mg Powder and solvent for solution for injection Intravenous Use 750 mg 6 ml Portugal GlaxoWellcome Farmacêutica Lda Rua Dr António Loureiro Borges no3 Arquiparque – Miraflores 1495-131 Algés PORTUGAL Curoxime 750 mg Powder and solvent for solution for injection Intramuscular Use 750 mg 3 ml Romania Glaxo Operations UK Limited, GlaxoSmithKline House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, UNITED KINGDOM Zinacef 750 mg Powder for Injection Intravenous Use 750 mg 6 ml Romania Glaxo Operations UK Limited, GlaxoSmithKline House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, UNITED KINGDOM Zinacef 750 mg Powder for Injection Intramuscular Use 750 mg 3 ml Slovenia GSK d.o.o., Ljubljana Cvetkova ulica 29 SI-1000 Ljubljana SLOVENIA Zinacef 1 500 mg prašek za raztopino za injiciranje ali infundiranje 1,5 g Powder for Solution for injection or Infusion Intravenous Use 1,5 g 15 ml/ 1,5 g 50 ml Slovenia GSK d.o.o., Ljubljana Cvetkova ulica 29SI-1000 Ljubljana SLOVENIA Zinacef 750 mg prašek za raztopino za injiciranje ali infundiranje 750 mg Powder for solution for injection or infusion Intramuscular Use/Intravenous Use 750 mg/3 ml 750 mg 6 ml Sweden GlaxoSmithKline AB Box 516 169 29 Solna SWEDEN Zinacef Powder for solution for Infusion Intravenous Use Sweden GlaxoSmithKline AB Box 516 169 29 Solna SWEDEN Zinacef Powder for solution for Injection Intravenous Use Sweden GlaxoSmithKline AB Box 516 169 29 Solna SWEDEN Zinacef Powder for Solution/Suspension for Injection Intramuscular Use United Kingdom Glaxo Operations UK Ltd, Stockley Park West, Uxbridge, Middlesex, UB11 1BT Zinacef 1,5 g Powder for Injection Intravenous Use and intramuscular use United Kingdom Glaxo Operations UK Ltd, Stockley Park West, Uxbridge, Middlesex, UB11 1BT Zinacef 250 mg Powder for Injection Intravenous Use and intramuscular use United Kingdom Glaxo Operations UK Ltd, Stockley Park West, Uxbridge, Middlesex, UB11 1BT Zinacef 750 mg Powder for Injection Intravenous Use and intramuscular use