EN Official Journal of the European Union C 231/20

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 August 2009 to 31 August 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 231/05

— Issuing of a marketing authorisation (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 authorisation Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 3.8.2009 Afinitor Everolimus Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/09/538/001-006 Tablet L01XE10 5.8.2009 3.8.2009 Samsca Tolvaptan Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU UNITED KINGDOM EU/1/09/539/001-004 Tablet C03XA01 5.8.2009

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

Date of the decision Name of the medicinal product Holder of the marketing authorisation Number of the entry in the Community Register Date of notification 3.8.2009 SUTENT Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/06/347/001-008 5.8.2009 3.8.2009 Baraclude Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/06/343/001-007 5.8.2009 3.8.2009 INTELENCE Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË EU/1/08/468/001 5.8.2009 3.8.2009 Revatio Pfizer Limited Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/05/318/001 5.8.2009 3.8.2009 PegIntron Schering Plough Europe Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË EU/1/00/131/001-050 5.8.2009 3.8.2009 Champix Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/06/360/001-012 5.8.2009 3.8.2009 FOSAVANCE Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/05/310/001-009 5.8.2009 6.8.2009 Lucentis Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/06/374/001 10.8.2009 6.8.2009 TESAVEL Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/07/435/001-018 10.8.2009 6.8.2009 Trevaclyn Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/458/001-014 10.8.2009 6.8.2009 Tasigna Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/422/001-004 10.8.2009 6.8.2009 Pelzont Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/460/001-014 10.8.2009 6.8.2009 Tredaptive Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/459/001-014 10.8.2009 7.8.2009 CELSENTRI Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/07/418/001-010 11.8.2009 7.8.2009 Prepandrix GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/08/453/002 11.8.2009 7.8.2009 Lyrica Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/04/279/001-043 11.8.2009 7.8.2009 Revlimid Celgene Europe Limited Riverside House Riverside Walk Windsor Berkshire SL4 1NA UNITED KINGDOM EU/1/07/391/001-004 11.8.2009 13.8.2009 Oprymea KRKA, d. d. Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto SLOVENIJA EU/1/08/469/001-025 17.8.2009 13.8.2008 Clopidogrel BMS Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/08/464/001-019 17.8.2009 13.8.2008 Clopidogrel Winthrop Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France 75013 Paris FRANCE EU/1/08/465/001-019 17.8.2009 18.8.2009 Nobilis Influenza H5N6 Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND EU/2/07/076/001-004 20.8.2009 20.8.2009 Lyrica Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/04/279/001-043 24.8.2009 20.8.2009 SUTENT Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/06/347/001-008 24.8.2009 20.8.2009 TESAVEL Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/07/435/001-018 24.8.2009 20.8.2009 Pramipexole Teva Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND EU/1/08/490/001-016 24.8.2009 20.8.2009 Pradaxa Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/08/442/001-008 24.8.2009 20.8.2009 Apidra Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND EU/1/04/285/001-036 24.8.2009 21.8.2009 PEGASYS Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/02/221/001-010 25.8.2009 21.8.2009 Galvus Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/414/001-010 EU/1/07/414/018 25.8.2009 21.8.2009 TORISEL Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/07/424/001 25.8.2009 21.8.2009 Jalra Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/08/485/001-011 25.8.2009 21.8.2009 Mycophenolate mofetil Teva Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND EU/1/07/439/001-004 25.8.2009 21.8.2009 TARGRETIN Eisai Limited, European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN UNITED KINGDOM EU/1/01/178/001 25.8.2009 21.8.2009 AVANDIA SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS UNITED KINGDOM EU/1/00/137/002-018 25.8.2009 21.8.2009 Myfenax Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND EU/1/07/438/001-004 25.8.2009 21.8.2009 Kaletra Abbott Laboratories Ltd Queenborough Kent ME11 5EL UNITED KINGDOM EU/1/01/172/001-006 25.8.2009 21.8.2009 Myozyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND EU/1/06/333/001-003 25.8.2009 21.8.2009 Luminity Lantheus MI UK Limited One South Place London EC2M 2WG UNITED KINGDOM EU/1/06/361/001-002 25.8.2009 21.8.2009 Januvia Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/07/383/001-018 25.8.2009 21.8.2009 Rotarix GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/05/330/001-011 25.8.2009 21.8.2009 Privigen CSL Behring GmbH Emil von Behring Strasse 76 35041 Marburg DEUTSCHLAND EU/1/08/446/001-006 25.8.2009 21.8.2009 Competact Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych London WC2B 4AE UNITED KINGDOM EU/1/06/354/001-009 25.8.2009 21.8.2009 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 25.8.2009 21.8.2009 Mabthera Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/98/067/001-002 25.8.2009 25.8.2009 Epoetin alfa Hexal Hexal AG. Industriestrasse 25 83607 Holzkirchen DEUTSCHLAND EU/1/07/411/001-020 27.8.2009 25.8.2009 Avandamet SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS UNITED KINGDOM EU/1/03/258/001-022 27.8.2009 25.8.2009 Ranexa Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare 1611 Luxembourg LUXEMBOURG EU/1/08/462/001-012 27.8.2009 25.8.2009 Tasigna Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/422/001-004 27.8.2009 25.8.2009 Binocrit Sandoz GmbH Biochemiestrasse 10 6250 Kundl ÖSTERREICH EU/1/07/410/001-020 27.8.2009 25.8.2009 Xiliarx Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/08/486/001-011 27.8.2009 27.8.2009 Thalidomide Celgene Celgene Europe Limited Riverside House Riverside Walk Windsor SL4 1NA UNITED KINGDOM EU/1/08/443/001 1.9.2009 27.8.2009 CELVAPAN Baxter AG Industriestraße 67 1221 Wien ÖSTERREICH EU/1/08/506/001 1.9.2009 27.8.2009 Champix Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/06/360/001-012 1.9.2009 27.8.2009 Zeffix Glaxo Group Ltd. Greenford Road Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/99/114/001-003 1.9.2009 27.8.2009 Iscover Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/98/070/001a-001b EU/1/98/070/002a-002b EU/1/98/070/003a-003b EU/1/98/070/004a-004b EU/1/98/070/005a-005b EU/1/98/070/006a-006b EU/1/98/070/007a-007b EU/1/98/070/008-010 EU/1/98/070/011a-011b 1.9.2009 27.8.2009 Xeristar Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/04/297/001-008 31.8.2009 27.8.2009 Vfend Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/02/212/001-026 1.9.2009 28.8.2009 Pelzont Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/460/001-014 1.9.2009 28.8.2009 Tredaptive Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/459/001-014 1.9.2009 28.8.2009 Trevaclyn Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/458/001-014 1.9.2009 28.8.2009 Irbesartan Krka KRKA, d.d. Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto SLOVENIJA EU/1/08/480/001-018 1.9.2009 28.8.2009 Volibris Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/08/451/001-004 1.9.2009 28.8.2009 Panretin Eisai Limited, European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN UNITED KINGDOM EU/1/00/149/001 1.9.2009 28.8.2009 Humira Abbott Laboratories Ltd Queenborough Kent ME11 5EL UNITED KINGDOM EU/1/03/256/001-010 1.9.2009 28.8.2009 Forsteo Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/03/247/001-002 1.9.2009 28.8.2009 Invanz Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/02/216/001-002 1.9.2009 28.8.2009 Zerit Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/96/009/001-009 1.9.2009 28.8.2009 Plavix Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France 75013 Paris FRANCE EU/1/98/069/001a-001b EU/1/98/069/002a-002b EU/1/98/069/003a-003b EU/1/98/069/004a-004b EU/1/98/069/005a-005b EU/1/98/069/006a-006b EU/1/98/069/007a-007b EU/1/98/069/008-010 EU/1/98/069/011a-011b 1.9.2009 28.8.2009 Abseamed Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 58638 Iserlohn DEUTSCHLAND EU/1/07/412/001-020 1.9.2009 28.8.2009 MicardisPlus Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/02/213/001-023 1.9.2009 28.8.2009 Eucreas Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/425/001-018 1.9.2009 28.8.2009 Aldara Meda AB Pipers väg 2 SE-170 73 Solna SVËRIGE EU/1/98/080/001 1.9.2009 28.8.2009 Xelevia Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/07/382/001-018 1.9.2009 31.8.2009 Betaferon Bayer Schering Pharma AG Müllerstrasse 170-178 13342 Berlin DEUTSCHLAND EU/1/95/003/009-010 2.9.2009 31.8.2009 Neupro Schwarz Pharma Ltd Shannon, Industrial Estate Co.Clare IRELAND EU/1/05/331/001-055 2.9.2009 31.8.2009 Icandra Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/08/484/001-018 2.9.2009 31.8.2009 Mimpara Amgen Europe B.V. Minervum 7061 4817 ZK Breda NEDERLAND EU/1/04/292/001-012 2.9.2009 31.8.2009 Tandemact Takeda Global Research and Development Centre (Europe) Ltd. 61 Aldwich London WC2B 4AE UNITED KINGDOM EU/1/06/366/005-022 2.9.2009 31.8.2009 Gardasil Sanofi Pasteur MSD, SNC 8 rue Jonas Salk 69007 Lyon FRANCE EU/1/06/357/001-021 2.9.2009 31.8.2009 Atripla Bristol-Myers Squibb and Gilead Sciences Limited Unit 13, Stillorgan Industrial Park Blackrock, Co.Dublin IRELAND EU/1/07/430/001-002 2.9.2009

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

Date of the decision Name of the medicinal product Holder of the marketing authorisation Number of the entry in the Community Register Date of notification 27.8.2009 Aivlosin ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS UNITED KINGDOM EU/2/04/044/001-010 31.8.2009 31.8.2009 Locatim Biokema Anstalt Pflugstrasse 12 9490 Vaduz, Fürstentum LIECHTENSTEIN EU/2/99/011/001 2.9.2009

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.