EN Official Journal of the European Union C 264/9

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

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

2012/C 264/02

— 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 31.7.2012 Tavanic and associated names See Annex I See Annex I 2.8.2012





— Refusal of 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 6.7.2012 Ethinylestradiol-Drospirenone 24 + 4 and associated names See Annex II See Annex II 10.7.2012

(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 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 Austria Sanofi-aventis GmbH Leonard-Bernstein-Straße 10, A-1220 Vienna Tavanic 250 mg Filmtabletten 250 mg Film-coated tablets Oral use Austria Sanofi-aventis GmbH Leonard-Bernstein-Straße 10, A-1220 Vienna Tavanic 500 mg Filmtabletten 500 mg Film-coated tablets Oral use Austria Sanofi-aventis GmbH Leonard-Bernstein-Straße 10, A-1220 Vienna Tavanic Infusionsflasche 5 mg/ml Solution for infusion Intravenous use Belgium Sanofi-aventis Belgium Culliganlaan, 1C 1831 Diegem - Belgium Tavanic 250 mg filmomhulde tabletten 250 mg Film-coated tablets Oral use Belgium Sanofi-aventis Belgium Culliganlaan, 1C 1831 Diegem - Belgium Tavanic 500 mg filmomhulde tabletten 500 mg Film-coated tablets Oral use Belgium Sanofi-aventis Belgium Culliganlaan, 1C 1831 Diegem - Belgium Tavanic 5 mg/ml oplossing voor infusie 5 mg/ml Solution for infusion Intravenous use Bulgaria Sanofi-Avenstis Bulgaria EOOD, Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8 Tavanic 250 mg Film-coated tablets Oral use Bulgaria Sanofi-Avenstis Bulgaria EOOD, Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8 Tavanic 500 mg Film-coated tablets Oral use Bulgaria Sanofi-Avenstis Bulgaria EOOD, Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8 Tavanic 5 mg/ml Solution for infusion Intravenous use Cyprus Sanofi-aventis Cyprus Ltd, 14 Charalambou Mouskou street, 2015 – Nicosia, Cyprus Tavanic 250 mg Film-coated tablets Oral use Cyprus Sanofi-aventis Cyprus Ltd, 14 Charalambou Mouskou street, 2015 – Nicosia, Cyprus Tavanic 500 mg Film-coated tablets Oral use Cyprus Sanofi-aventis Cyprus Ltd, 14 Charalambou Mouskou street, 2015 – Nicosia, Cyprus Tavanic 5 mg/ml Solution for infusion Intravenous use Czech Republic sanofi-aventis, s.r.o. Evropská 846/176a 160 00 Praha 6 Czech Republic Tavanic i.v. 5 mg/ml Solution for infusion Intravenous use Estonia sanofi-aventis Estonia OÜ, Pärnu mnt 139 E/2, 11317 Tallinn, Estonia Tavanic 250 mg Film-coated tablets Oral use Estonia sanofi-aventis Estonia OÜ, Pärnu mnt 139 E/2, 11317 Tallinn, Estonia Tavanic 500 mg Film-coated tablets Oral use Estonia sanofi-aventis Estonia OÜ, Pärnu mnt 139 E/2, 11317 Tallinn, Estonia Tavanic 5 mg/ml Solution for infusion Intravenous use Finland sanofi-aventis Oy Huopalahdentie 24 00350 Helsinki, Finland Tavanic 250 mg Film-coated tablets Oral use Finland sanofi-aventis Oy Huopalahdentie 24 00350 Helsinki, Finland Tavanic 500 mg Film-coated tablets Oral use Finland sanofi-aventis Oy Huopalahdentie 24 00350 Helsinki, Finland Tavanic 5 mg/ml Solution for infusion Intravenous use France Sanofi-aventis France 1-13 Boulevard Romain Rolland 75014 Paris FRANCE TAVANIC 250 mg comprimé pelliculé sécable 250 mg Film-coated tablets Oral use France Sanofi-aventis France 1-13 Boulevard Romain Rolland 75014 Paris FRANCE TAVANIC 500 mg comprimé pelliculé sécable 500 mg Film-coated tablets Oral use France Sanofi-aventis France 1-13 Boulevard Romain Rolland 75014 Paris FRANCE TAVANIC 5 mg/ml solution pour perfusion 5 mg/ml Solution for infusion Intravenous use Germany Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Gebäude K703 65926 Frankfurt am Main, Deutschland Tavanic 250 mg Filmtabletten 250 mg Film-coated tablets Oral use Germany Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Gebäude K703 65926 Frankfurt am Main, Deutschland Tavanic 500 mg Filmtabletten 500 mg Film-coated tablets Oral use Germany Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Gebäude K703 65926 Frankfurt am Main, Deutschland Tavanic 5 mg/ml Infusionslösung 5 mg/ml Solution for infusion Intravenous use Greece sanofi-aventis AEBE 348 Syngrou avenue-Building A 176 74 Kalithea – Athens GR-Greece Tavanic 250 mg Film-coated tablets Oral use Greece sanofi-aventis AEBE 348 Syngrou avenue-Building A 176 74 Kalithea – Athens GR-Greece Tavanic 500 mg Film-coated tablets Oral use Greece sanofi-aventis AEBE 348 Syngrou avenue-Building A 176 74 Kalithea – Athens GR-Greece Tavanic 5 mg/1 ml Solution for infusion Intravenous use Hungary sanofi-aventis Zrt. To u. 1-5. 1045 Budapest, Hungary Tavanic 250 mg Film-coated tablets Oral use Hungary sanofi-aventis Zrt. To u. 1-5. 1045 Budapest, Hungary Tavanic 500 mg Film-coated tablets Oral use Hungary sanofi-aventis Zrt. To u. 1-5. 1045 Budapest, Hungary Tavanic 5 mg/ml Solution for infusion Intravenous use Ireland sanofi-aventis Ireland Ltd., Citywest Business Campus, Dublin 24, Ireland Tavanic 250 mg film-coated tablets 250 mg Film-coated tablets Oral use Ireland sanofi-aventis Ireland Ltd., Citywest Business Campus, Dublin 24, Ireland Tavanic 500 mg film-coated tablets 500 mg Film-coated tablets Oral use Ireland sanofi-aventis Ireland Ltd., Citywest Business Campus, Dublin 24, Ireland Tavanic 5 mg/ml solution for infusion 5 mg/ml Solution for infusion Intravenous use Italy sanofi-aventis S.p.A. Viale Luigi Bodio 37/B 20158 Milan Italy TAVANIC 250 mg Film-coated tablets Oral use Italy sanofi-aventis S.p.A. Viale Luigi Bodio 37/B 20158 Milan Italy TAVANIC 500 mg Film-coated tablets Oral use Italy sanofi-aventis S.p.A. Viale Luigi Bodio 37/B 20158 Milan Italy TAVANIC 5 mg/ml Solution for infusion Intravenous use Lithuania UAB ‘SANOFI-AVENTIS LIETUVA’, A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania Tavanic 250 mg Film-coated tablets Oral use Lithuania UAB ‘SANOFI-AVENTIS LIETUVA’, A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania Tavanic 500 mg Film-coated tablets Oral use Lithuania UAB ‘SANOFI-AVENTIS LIETUVA’, A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania Tavanic 5 mg/ml Solution for infusion Intravenous use Luxembourg Sanofi-aventis Belgium Culliganlaan, 1C 1831 Diegem - Belgium Tavanic 250 mg comprimés pelliculés 250 mg Film-coated tablets Oral use Luxembourg Sanofi-aventis Belgium Culliganlaan, 1C 1831 Diegem - Belgium Tavanic 500 mg comprimés pelliculés 500 mg Film-coated tablets Oral use Luxembourg Sanofi-aventis Belgium Culliganlaan, 1C 1831 Diegem - Belgium Tavanic 5 mg/ml solution pour perfusion 5 mg/ml Solution for infusion Intravenous use Malta Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta Tavanic 250 mg film coated tablets 250 mg Film-coated tablets Oral use Malta Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta Tavanic 500 mg film coated tablets 500 mg Film-coated tablets Oral use Malta Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta Tavanic 5 mg/ml solution for infusion 5 mg/ml Solution for infusion Intravenous use Netherlands sanofi-aventis Netherlands B.V., Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands Tavanic 250 250 mg Film-coated tablets Oral use Netherlands sanofi-aventis Netherlands B.V., Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands Tavanic 500 500 mg Film-coated tablet Oral use Netherlands sanofi-aventis Netherlands B.V., Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands Tavanic IV 5 mg/ml Solution for infusion Intravenous use Poland Sanofi-Aventis Deutschland GmbH Brüningstrasse 50 D-65926 Frankfurt am Main, Germany Tavanic 250 250 mg Film-coated tablets Oral use Poland Sanofi-Aventis Deutschland GmbH Brüningstrasse 50 D-65926 Frankfurt am Main, Germany Tavanic 500 500 mg Film-coated tablets Oral use Poland Sanofi-Aventis Deutschland GmbH Brüningstrasse 50 D-65926 Frankfurt am Main, Germany Tavanic 5 mg/ml Solution for infusion Intravenous use Portugal SANOFI-AVENTIS – Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7 – 3o Piso 2740-244 Porto Salvo TAVANIC 250 mg Film-coated tablets Oral use Portugal SANOFI-AVENTIS – Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7 – 3o Piso 2740-244 Porto Salvo TAVANIC 500 mg Film-coated tablets Oral use Portugal SANOFI-AVENTIS – Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7 – 3o Piso 2740-244 Porto Salvo TAVANIC 5 mg/ml Solution for infusion Intravenous use Slovak Republic sanofi-aventis Slovakia s.r.o., Einsteinova 24, 85101 Bratislava, Slovak Republic Tavanic 500 mg 500 mg Film-coated tablets Oral use Slovak Republic sanofi-aventis Slovakia s.r.o., Einsteinova 24, 85101 Bratislava, Slovak Republic Tavanic i.v. 500 mg 5 mg/ml Solution for infusion Intravenous use Slovenia sanofi-aventis d.o.o, Dunajska 151, 1000 Ljubljana, Slovenia Tavanic 250 mg filmsko obložene tablete 250 mg Film-coated tablets Oral use Slovenia sanofi-aventis d.o.o, Dunajska 151, 1000 Ljubljana, Slovenia Tavanic 500 mg filmsko obložene tablete 500 mg Film-coated tablets Oral use Slovenia sanofi-aventis d.o.o, Dunajska 151, 1000 Ljubljana, Slovenia Tavanic 5 mg/ml raztopina za infundiranje 5 mg/ml Solution for infusion Intravenous use Spain Sanofi-aventis, S.A. Josep Pla, 2 08019 – Barcelona Spain Tavanic 500 mg comprimidos recubiertos con película 500 mg Film-coated tablets Oral use Spain Sanofi-aventis, S.A. Josep Pla, 2 08019 – Barcelona Spain Tavanic 5 mg/ml solución para perfusión 5 mg/ml Solution for infusion Intravenous use Sweden sanofi-aventis AB Box 141 42 167 14 Bromma Sweden Tavanic 250 mg Film-coated tablets Oral use Sweden sanofi-aventis AB Box 141 42 167 14 Bromma Sweden Tavanic 500 mg Film-coated tablets Oral use Sweden sanofi-aventis AB Box 141 42 167 14 Bromma Sweden Tavanic 5 mg/ml Solution for infusion Intravenous use United Kingdom Aventis Pharma Limited, 50 Kings Hill Avenue Kings Hill West Malling Kent ME19 4AH United Kingdom (Trading as: Sanofi-aventis One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom) Tavanic 250 mg film-coated tablets 250 mg Film-coated tablets Oral use United Kingdom Aventis Pharma Limited, 50 Kings Hill Avenue Kings Hill West Malling Kent ME19 4AH United Kingdom (Trading as: Sanofi-aventis One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom) Tavanic 500 mg film-coated tablets 500 mg Film-coated tablets Oral use United Kingdom Aventis Pharma Limited, 50 Kings Hill Avenue Kings Hill West Malling Kent ME19 4AH United Kingdom (Trading as: Sanofi-aventis One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom) Tavanic 5 mg/ml solution for infusion 5 mg/ml Solution for infusion Intravenous use