EN Official Journal of the European Union C 73/5

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

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

(2009/C 73/03)

— 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 4.2.2009 Nplate Romiplostim Amgen Europe B.V. Minervum 7061 4817 ZK Breda NEDERLAND EU/1/08/497/001-002 Powder for solution for injection B02BX04 6.2.2009 6.2.2009 Zarzio Filgrastim Sandoz GmbH Biochemiestraße 10 6250 Kundl ÖSTERREICH EU/1/08/495/001-008 Solution for injection or infusion L03AA02 10.2.2009 6.2.2009 Filgrastim Hexal Filgrastim HEXAL AG Industriestraße 25 83607 Holzkirchen DEUTSCHLAND EU/1/08/496/001-008 Solution for injection or infusion L03AA02 10.2.2009 17.2.2009 FIRMAGON Degarelix (as acetate) Ferring Pharmaceuticals A/S Kay Fiskers Plads 11 Copenhagen S 2300 DANMARK EU/1/08/504/001-002 Powder and solvent for solution for injection L02BX02 19.2.2009 19.2.2009 Thymanax Agomelatine Servier (Ireland) Industries Limited Gorey Road Arklow Co. Wicklow IRELAND EU/1/08/498/001-008 Film-coated tablet NO6AX22 23.2.2009 19.2.2009 Opgenra Eptotermin alfa Howmedica International S. de R. L. Raheen Business Park Limerick IRELAND EU/1/08/489/001 Powders for suspension for implantation M05BC02 23.2.2009 19.2.2009 Valdoxan Agomelatine Laboratoires Servier 22 rue Garnier 92200 Neuilly-sur-Seine FRANCE EU/1/08/499/001-008 Film-coated tablet NO6AX22 23.2.2009 24.2.2009 FABLYN Lasofoxifene Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/08/500/001-004 Film-coated tablet Non applicable 26.2.2009 24.2.2009 INTANZA Influenza Vaccine (split virion, inactivated) Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE EU/1/08/505/001-006 Suspension for injection J07BB02 26.2.2009 24.2.2009 IDflu Influenza Vaccine (split virion, inactivated) Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE EU/1/08/507/001-006 Suspension for injection J07BB02 26.2.2009 25.2.2009 Efient Prasugrel Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/08/503/001-014 Film-coated tablet Non applicable 27.2.2009

— 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 2.2.2009 Vfend Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ UNITED KINGDOM EU/1/02/212/001-026 5.2.2009 2.2.2009 Gardasil Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE EU/1/06/357/001-021 4.2.2009 2.2.2009 Silgard Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/06/358/001-021 4.2.2009 2.2.2009 Vimpat UCB Pharma S.A. Allée de la Recherche 60 1070 Bruxelles BELGIQUE EU/1/08/470/001-016 4.2.2009 2.2.2009 DuoTrav Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD UNITED KINGDOM EU/1/06/338/001-003 4.2.2009 4.2.2009 Elaprase Shire Human Genetic Therapies AB Svardvagen 11D 182 33 Danderyd SVERIGE EU/1/06/365/001-003 6.2.2009 6.2.2009 REYATAZ Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/03/267/001-010 10.2.2009 6.2.2009 Extavia Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/08/454/001-004 10.2.2009 10.2.2009 Pradaxa Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/08/442/001-008 12.2.2009 10.2.2009 SUTENT Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ UNITED KINGDOM EU/1/06/347/001-006 12.2.2009 10.2.2009 Baraclude Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/06/343/001-007 12.2.2009 10.2.2009 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/06/363/001-011 12.2.2009 10.2.2009 Xolair Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/05/319/005- 010 12.2.2009 10.2.2009 TachoSil Nycomed Austria GmbH St.-Peter-Straße 25 4020 Linz ÖSTERREICH EU/1/04/277/001-004 12.2.2009 10.2.2009 Abraxane Abraxis BioSciences Limited 2nd floor Titan Court 3 Bishops Sq Hatfield AL 10 9NA UNITED KINGDOM EU/1/07/428/001 13.2.2009 10.2.2009 Arava Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND EU/1/99/118/001-010 12.2.2009 10.2.2009 IVEMEND Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/07/437/001-002 12.2.2009 11.2.2009 Zonegran Eisai Limited 3 Shortlands London W6 8EE UNITED KINGDOM EU/1/04/307/001-013 13.2.2009 13.2.2009 Clopidogrel Winthrop Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France 75013 Paris FRANCE EU/1/08/465/001 EU/1/08/465/003 EU/1/08/465/005 EU/1/08/465/007 EU/1/08/465/009 EU/1/08/465/011 EU/1/08/465/013 EU/1/08/465/018-019 17.2.2009 13.2.2009 Clopidogrel BMS Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/08/464/001 EU/1/08/464/003 EU/1/08/464/005 EU/1/08/464/007 EU/1/08/464/009 EU/1/08/464/011 EU/1/08/464/013 EU/1/08/464/018-019 17.2.2009 13.2.2009 Dafiro Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/06/371/001-036 17.2.2009 13.2.2009 Lyrica Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ UNITED KINGDOM EU/1/04/279/001-043 17.2.2009 13.2.2009 Copalia Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/06/372/001-036 17.2.2009 13.2.2009 Exforge Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/06/370/001-036 17.2.2009 13.2.2009 Tasmar Meda Actiebolag Pipers väg 2A Box 906 170 09 Solna SVERIGE EU/1/97/044/001-008 18.2.2009 Valeant Pharmaceuticals Limited Cedarwood Chineham Business Park Crockford Lane Basingstoke RG24 8WD UNITED KINGDOM 13.2.2009 Imprida Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/06/373/001-036 17.2.2009 17.2.2009 Temodal Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 1180 Bruxelles/1180 Brussel BELGIQUE/BELGIË EU/1/98/096/001-022 19.2.2009 19.2.2009 Zerene Meda AB Pipers väg 2A 170 09 Solna SVERIGE EU/1/99/099/001-006 23.2.2009 19.2.2009 Insuman Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND EU/1/97/030/170-189 23.2.2009 19.2.2009 Sonata Meda AB Pipers väg 2A 170 09 Solna SVERIGE EU/1/99/102/001-006 23.2.2009 19.2.2009 Insulin Human Winthrop Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND EU/1/06/368/143-162 23.2.2009 20.2.2009 Myozyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND EU/1/06/333/001-003 24.2.2009 20.2.2009 Evoltra Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND EU/1/06/334/001-004 24.2.2009 20.2.2009 Luminity Bristol-Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185/Terhulpsesteenweg 185 1170 Bruxelles/1180 Brussel BELGIQUE/BELGIË EU/1/06/361/001-002 24.2.2009 20.2.2009 Bondenza Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/03/266/003-006 24.2.2009 23.2.2009 Myozyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND EU/1/06/333/001-003 25.2.2009 23.2.2009 BeneFIX Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/97/047/001-007 25.2.2009 23.2.2009 Bonviva Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/03/265/003-006 25.2.2009 23.2.2009 Mabthera Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/98/067/001-002 25.2.2009 24.2.2009 Thalidomide Celgene Celgene Europe Limited Riverside House Riverside Walk Windsor SL4 1NA UNITED KINGDOM EU/1/08/443/001 26.2.2009 24.2.2009 Irbesartan HCT BMS Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/06/369/001-028 26.2.2009 24.2.2009 Viracept Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/97/054/004-005 26.2.2009 24.2.2009 Revlimid Celgene Europe Limited Riverside House Riverside Walk Windsor Berkshire SL4 1NA UNITED KINGDOM EU/1/07/391/001-004 26.2.2009 24.2.2009 Abilify Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU UNITED KINGDOM EU/1/04/276/001-020 EU/1/04/276/024-036 26.2.2009 25.2.2009 ORENCIA Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/07/389/001-003 27.2.2009 25.2.2009 Dynastat Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ UNITED KINGDOM EU/1/02/209/001-008 27.2.2009 25.2.2009 Levitra Bayer AG 51368 Leverkusen DEUTSCHLAND EU/1/03/248/001-012 27.2.2009 25.2.2009 Forsteo Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/03/247/001-002 27.2.2009 25.2.2009 Zerit Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/96/009/001-009 27.2.2009 25.2.2009 Irbesartan Winthrop SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174 avenue de France 75013 Paris FRANCE EU/1/06/376/001-033 27.2.2009 25.2.2009 HUMIRA Abbott Laboratories Ltd Queenborough Kent ME11 5EL UNITED KINGDOM EU/1/03/256/001-010 27.2.2009 25.2.2009 Vivanza Bayer AG 51368 Leverkusen DEUTSCHLAND EU/1/03/249/001-012 27.2.2009 25.2.2009 Advagraf Astellas Pharma Europe B.V. Elisabethhof 19 2353 EW Leiderdorp NEDERLAND EU/1/07/387/001-010 27.2.2009 25.2.2009 Ranexa Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare L-1611 Luxembourg Luxembourg EU/1/08/462/001-012 27.2.2009 CV Therapeutics Europe Limited 15 Meadway Court Rutherford Close Stevenage Hertfordshire SG1 2EF UNITED KINGDOM 26.2.2009 Advate Baxter AG Industriesstraße 67 1220 Vienna ÖSTERREICH EU/1/03/271/001-006 2.3.2009 26.2.2009 ReFacto AF Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/99/103/001-004 2.3.2009 26.2.2009 Myfenax Teva Pharma B.V. Computerweg 10 DR Utrecht 3542 NEDERLAND EU/1/07/438/001-004 2.3.2009 26.2.2009 Fasturtec Sanofi-Aventis 174 avenue de France 75013 Paris FRANCE EU/1/00/170/001-002 2.3.2009 26.2.2009 Mycophenolate mofetil Teva Teva Pharma B.V. Computerweg 10 DR Utrecht 3542 NEDERLAND EU/1/07/439/001-004 2.3.2009 26.2.2009 Pradaxa Boehringer IngelheimInternational GmbH Binger Straße 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/08/442/001-008 2.3.2009 26.2.2009 Protopic Astellas Pharma GmbH Neumarkter Str. 61 81673 München DEUTSCHLAND EU/1/02/201/001-006 4.3.2009 26.2.2009 Volibris Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/08/451/001-004 2.3.2009 26.2.2009 Telzir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/04/282/001-002 2.3.2009 26.2.2009 Xeristar Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/04/297/001-008 2.3.2009 26.2.2009 Karvezide Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/98/085/001-034 2.3.2009 26.2.2009 Karvea Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/97/049/001-039 2.3.2009 26.2.2009 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France 75013 Paris FRANCE EU/1/98/086/001-034 2.3.2009 26.2.2009 Oprymea KRKA, d. d. Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto SLOVENIJA EU/1/08/469/001-025 2.3.2009 26.2.2009 Aprovel Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France 75013 Paris FRANCE EU/1/97/046/001-039 2.3.2009 26.2.2009 Tasigna Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/422/001-004 3.3.2009 26.2.2009 Baraclude Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/06/343/001-007 3.3.2009 26.2.2009 REYATAZ Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/03/267/001-010 3.3.2009 26.2.2009 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/06/363/001-011 3.3.2009 26.2.2009 Tyverb Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/07/440/001-002 3.3.2009 26.2.2009 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP UNITED KINGDOM EU/1/04/295/001 3.3.2009 27.2.2009 Ariclaim Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/04/283/001-012 3.3.2009

— 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 10.2.2009 Loxicom Meloxicam Norbrook Laboratories Limited Station Works Newry Co. Down BT35 6JP UNITED KINDGOM EU/2/08/090/001-005 Oral Suspension QM01AC06 12.2.2009 EU/2/08/090/006-008 Solution for Injection 11.2.2009 STARTVAC Escherichia coli J5: > 50 RED60 Staph. Aureus (CP8): > 50 RED80 Laboratorios Hipra, S.A. Avda. La Selva, 135 17170 Amer (Girona) ESPAÑA EU/2/08/092/001-007 Emulsion for injection QI02 AB 13.2.2009

— 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 12.2.2009 Purevax RCCh Merial 29 Avenue Tony Garnier 69007 Lyon FRANCE EU/2/04/049/001-002 16.2.2009 13.2.2009 Purevax RCP FeLV Merial 29 Avenue Tony Garnier 69007 Lyon FRANCE EU/2/04/048/001-002 17.2.2009 13.2.2009 Purevax RCPCh FeLV Merial 29 Avenue Tony Garnier 69007 Lyon FRANCE EU/2/04/047/001-002 17.2.2009 17.2.2009 Purevax RCPCh Merial 29 Avenue Tony Garnier 69007 Lyon FRANCE EU/2/04/050/001-002 19.2.2009 17.2.2009 ProMeris Duo Fort Dodge Animal Health Holland C.J. van Houtenlaan 36 1381 CP Weesp NEDERLAND EU/2/06/065/001-010 19.2.2009 17.2.2009 Purevax RC Merial 29 Avenue Tony Garnier 69007 Lyon FRANCE EU/2/04/051/001-002 20.2.2009 17.2.2009 Purevax RCP Merial 29 Avenue Tony Garnier 69007 Lyon FRANCE EU/2/04/052/001-002 19.2.2009

— Suspension of a marketing authorization (Article 45 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 20.2.2009 Porcilis Pesti Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND EU/2/99/016/001-006 24.2.2009

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.