EN Official Journal of the European Union C 276/2

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2008 to 30 September 2008

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )

(2008/C 276/02)

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted

Date of the decision Name of the medicinal product INN (International Non-Proprietary Name) Holder of the marketing authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 12.9.2008 Oprymea Pramipexole KRKA, d.d. Šmarješka cesta 6 SLO-8501 Novo mesto EU/1/08/469/001-025 Tablet NO4BC05 15.9.2008 15.9.2008 Tevagrastim Filgrastim Teva Generics GmbH Kandelstr. 10 D-79199 Kirchzarten EU/1/08/445/001-008 Solution for injection or infusion L03AA02 17.9.2008 15.9.2008 Biograstim Filgrastim CT Arzneimittel GmbH Lengeder Straße 42a D-13407 Berlin EU/1/08/450/001-008 Solution for injection or infusion L03AA02 17.9.2008 15.9.2008 Ratiograstim Filgrastim ratiopharm GmbH Graf-Arco-Straße 3 D-89079 Ulm EU/1/08/444/001-008 Solution for injection or infusion L03AA02 17.9.2008 15.9.2008 Filgrastim ratiopharm Filgrastim ratiopharm GmbH Graf-Arco-Straße 3 D-89079 Ulm EU/1/08/449/001-008 Solution for injection or infusion L03AA02 17.9.2008 26.9.2008 Prepandemic influenza vaccine (H5N1) (split virion inactivated adjuvanted) GlaxoSmithKline Biologicals Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) A/VietNam/1194/2004 NIBRG-14 GlaxoSmithKline Biologicals S.A. rue de l'Institut, 89 B-1330 Rixensart EU/1/08/478/001 Suspension and emulsion for emulsion for injection J07BB02 30.9.2008 30.9.2008 Xarelto Rivaroxaban Bayer HealthCare AG D-51368 Leverkusen EU/1/08/472/001-008 Film-coated tablet B01AX06 2.10.2008

— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 1.9.2008 Aranesp Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/01/185/001-073 3.9.2008 1.9.2008 Adenuric Beaufour Ipsen Pharma 24, rue Erlanger F-75781 Paris Cedex 16 EU/1/08/447/001-004 3.9.2008 Ipsen Manufacturing Ireland Ltd (IMIL) Blanchardstown Industrial Park Snugboro Road Dublin 15 Ireland 3.9.2008 1.9.2008 Rotarix GlaxoSmithKline Biologicals s.a. rue de l'Institut, 89 B-1330 Rixensart EU/1/05/330/001-011 3.9.2008 1.9.2008 Zostavax Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/341/001-013 3.9.2008 2.9.2008 Ziagen Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/99/112/001-002 4.9.2008 2.9.2008 Lucentis Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/374/001 4.9.2008 2.9.2008 Olanzapine Neopharma Neopharma Limited 57 High Street Odiham Hampshire RG29 1LF United Kingdom EU/1/07/426/001-011 4.9.2008 2.9.2008 SonoVue Bracco International B.V. Strawinskylaan 3051 1077 ZX Amsterdam Nederland EU/1/01/177/002 4.9.2008 2.9.2008 Gardasil Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/357/001-021 5.9.2008 2.9.2008 Viramune Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/97/055/001-003 4.9.2008 2.9.2008 Ventavis Bayer Schering Pharma AG Müllerstraße 170-178 D-13342 Berlin EU/1/03/255/001-006 4.9.2008 2.9.2008 Silgard Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/06/358/001-021 4.9.2008 2.9.2008 Cetrotide Serono Europe Limited 56 Marsh Wall London E14 9TP United Kingdom EU/1/99/100/001-003 5.9.2008 2.9.2008 Olanzapine Teva - Teva Pharma B.V. Computerweg 10 DR Utrecht 3542 Nederland EU/1/07/427/001-057 4.9.2008 2.9.2008 Elaprase Shire Human Genetic Therapies AB Rinkebyvägen 11B S-182 36 Danderyd EU/1/06/365/001-003 4.9.2008 3.9.2008 Tysabri Elan Pharma International Ltd Monksland Athlone County Westmeath Ireland EU/1/06/346/001 8.9.2008 3.9.2008 Comtess Orion Corporation Orionintie 1 FI-02200 Espoo EU/1/98/082/001-003 EU/1/98/082/005 8.9.2008 3.9.2008 Aldara Meda AB Pipers väg 2A S-170 73 Solna EU/1/98/080/001 5.9.2008 3.9.2008 Tamiflu Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/222/001-004 5.9.2008 3.9.2008 Mirapexin Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/97/051/001-006 EU/1/97/051/009-012 5.9.2008 3.9.2008 Aldara Meda AB Pipers väg 2A S-170 73 Solna EU/1/98/080/001 5.9.2008 3.9.2008 Comtan Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/98/081/001-004 8.9.2008 3.9.2008 Cialis Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/02/237/001-008 5.9.2008 5.9.2008 Mircera Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/07/400/017-021 9.9.2008 5.9.2008 Herceptin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/00/145/001 9.9.2008 5.9.2008 Puregon Organon N.V. Kloosterstraat 6 Postbus 20 5340 BH Oss Nederland EU/1/96/008/038-041 9.9.2008 5.9.2008 Epivir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/96/015/001-005 9.9.2008 8.9.2008 Evra Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/02/223/001-003 10.9.2008 9.9.2008 Herceptin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/00/145/001 11.9.2008 12.9.2008 Viread Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/01/200/001-002 15.9.2008 15.9.2008 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/99/110/001-009 17.9.2008 15.9.2008 Glubrava Takeda Global Research and Development Centre (Europe) Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/07/421/001-009 17.9.2008 15.9.2008 Stalevo Orion Corporation Orionintie 1 FI-02200 Espoo EU/1/03/260/001-023 17.9.2008 16.9.2008 Combivir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/98/058/001-002 18.9.2008 17.9.2008 Optisulin Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/00/133/001-008 19.9.2008 17.9.2008 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/00/134/001-037 19.9.2008 22.9.2008 Emtriva Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/03/261/001-003 24.9.2009 22.9.2008 Emend Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/03/262/001-008 24.9.2008 26.9.2008 Aclasta Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/05/308/001-002 30.9.2008 26.9.2008 Thelin Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ United Kingdom EU/1/06/353/001-005 30.9.2008 29.9.2008 Mycamine Astellas Pharma Europe B.V. Elisabethhof 19 2353 EW Leiderdorp Nederland EU/1/08/448/001-002 1.10.2008 Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München 1.10.2008

— Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004)

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 26.9.2008 Exubera Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/05/327/001-018 30.9.2008

— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): Accepted

Date of the decision Name of the medicinal product INN (International Non-Proprietary Name) Holder of the marketing authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 9.9.2008 Trocoxil Mavacoxib Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom EU/2/08/084/001-005 Chewable tablets QM01AH92 11.9.2008

— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): Accepted

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 2.9.2008 Advocate Bayer Animal Health GmbH D-51368 Leverkusen EU/2/03/039/001-030 4.9.2008 Bayer HealthCare AG D-51368 Leverkusen 4.9.2008 5.9.2008 Profender Bayer Animal Health GmbH D-51368 Leverkusen EU/2/05/054/001-031 9.9.2008 Bayer HealthCare AG D-51368 Leverkusen 9.9.2008 15.9.2008 Oxyglobin Biopure Netherlands B.V. Parnassustoren Locatellikade 1 1076 AZ Amsterdam Nederland EU/2/99/015/002 17.9.2008 19.9.2008 DRAXXIN Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/2/03/041/001-005 23.9.2008 26.9.2008 PRAC-TIC Novartis Sanidad Animal S.L. Calle de la Marina, 206 E-Barcelona 08013 EU/2/06/066/001-012 30.9.2008

— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): Rejected

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 26.9.2008 Porcilis Pesti Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/99/016/001-006 30.9.2008

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

The European Medicines Agency 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom

(1) OJ L 136, 30.4.2004, p. 1.