EN Official Journal of the European Union C 73/16

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2009 to 28 February 2009

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

(2009/C 73/04)

— 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 4.2.2009 Nplate Amgen Europe B.V. Minervum 7061 4817 ZK Breda NEDERLAND This Decision is addressed to the Member States 6.2.2009 6.2.2009 Implanon See Annex I See Annex I 9.2.2009 16.2.2009 Diovan See Annex II See Annex II 17.2.2009 17.2.2009 FIRMAGON Ferring Pharmaceuticals A/S Kay Fiskers Plads 11 Copenhagen S 2300 DANMARK This Decision is addressed to the Member States 18.2.2009 19.2.2009 Valdoxan Laboratoires Servier 22 rue Garnier 92200 Neuilly-sur-Seine FRANCE This Decision is addressed to the Member States 23.2.2009 19.2.2009 Opgenra Howmedica International S. de R. L. Raheen Business Park Limerick IRELAND This Decision is addressed to the Member States 23.2.2009 19.2.2009 Thymanax Servier (Ireland) Industries Limited Gorey Road Arklow Co. Wicklow IRELAND This Decision is addressed to the Member States 23.2.2009 24.2.2009 FABLYN Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM This Decision is addressed to the Member States 25.2.2009 25.2.2009 Ranexa Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare L-1611 Luxembourg LUXEMBOURG CV Therapeutics Europe Limited 15 Meadway Court Rutherford Close Stevenage Hertfordshire SG1 2EF UNITED KINGDOM This Decision is addressed to the Member States 26.2.2009 25.2.2009 Efient Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND This Decision is addressed to the Member States 27.2.2009 26.2.2009 ReFacto AF Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM This Decision is addressed to the Member States 27.2.2009

(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 MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORIZATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Marketing Authorization Holder Applicant (Invented) Name Strength Pharmaceutical form Route of administration Austria N.V. Organon Kloosterstraat 6 PO Box 20 5349 AB, Oss NEDERLAND Implanon — Implantat 68 mg Implant Subcutaneous use Belgium N.V. Organon Kloosterstraat 6 PO Box 20 5340 BH, Oss NEDERLAND Implanon 68 mg Implant Subcutaneous use Czech Republic N.V. Organon Kloosterstraat 6 PO Box 20 5340 BH, Oss NEDERLAND Implanon 68 mg Implant Subcutaneous use Denmark N.V. Organon Kloosterstraat 6 PO Box 20 5340 BH, Oss NEDERLAND Implanon 68 mg Implant Subcutaneous use Finland N.V. Organon Kloosterstraat 6 PO Box 20 5340 BH, Oss NEDERLAND Implanon 68 mg Implant Subcutaneous use France Organon SA Immeuble Optima 10 rue Godefroy 92821 Puteaux Cedex FRANCE Implanon 68 mg Implant Subcutaneous use Germany Essex Pharma GmbH Thomas-Dehler-Straße, 27 81737 München DEUTSCHLAND Implanon 68 mg Implant Subcutaneous use Hungary N.V. Organon Kloosterstraat 6 PO Box 20 5340 BH, Oss NEDERLAND Implanon 68 mg Implant Subcutaneous use Iceland N.V. Organon Kloosterstraat 6 PO Box 20 5340 BH, Oss NEDERLAND Implanon 68 mg Implant Subcutaneous use Ireland Organon Ireland Ltd Drynam Road Swords Co. Dublin IRELAND Implanon 68 mg implant 68 mg Implant Subcutaneous use Italy N.V. Organon Kloosterstraat 6 PO Box 20 5340 BH, Oss NEDERLAND Implanon 68 mg Implant Subcutaneous use Luxembourg N.V. Organon Kloosterstraat 6 PO Box 20 5340 BH, Oss NEDERLAND Implanon 68 mg Implant Subcutaneous use Malta Organon Laboratories Ltd Cambridge Science Park Milton Road Cambridge CB4 0FL UNITED KINGDOM Implanon 68 mg Implant Subcutaneous use Netherlands N.V. Organon Kloosterstraat 6 PO Box 20 5340 BH, Oss NEDERLAND Implanon 68 mg 68 mg Implant Subcutaneous use Norway N.V. Organon Kloosterstraat 6 PO Box 20 5340 BH, Oss NEDERLAND Implanon 68 mg Implant Subcutaneous use Portugal Organon Portuguesa Produtos Químicos e Farmacêuticos, Lda Av. José Malhoa, 16B — 2° 1070-159 Lisboa PORTUGAL Implanon 68 mg Implant Subcutaneous use Slovak Republic N.V. Organon Kloosterstraat 6 PO Box 20 5340 BH, Oss NEDERLAND Implanon 68 mg Implant Subcutaneous use Spain Organon Española, S.A. Ctra. de Hospitalet, 147-149 Cityparc Ronda de Dalt Edificio Amsterdam 08940 Cornellá de Llobregat, Barcelona ESPAÑA Implanon 68 mg Implant Subcutaneous use Sweden N.V. Organon Kloosterstraat 6 PO Box 20 5340 BH, Oss NEDERLAND Implanon 68 mg Implant Subcutaneous use United Kingdom Organon Laboratories Ltd Cambridge Science Park Milton Road Cambridge CB4 0FL UNITED KINGDOM Implanon 68 mg Implant Subcutaneous use