EN Official Journal of the European Union C 260/6

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 September 2009 to 30 September 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 260/04

— 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 21.9.2009 Cayston Aztreonam Gilead Sciences International Limited Granta Park Abington Cambridge CB21 6GT UNITED KINGDOM EU/1/09/543/001 Powder and solvent for nebuliser solution J01DF01 23.9.2009 21.9.2009 Clopidogrel Sandoz Clopidogrel Acino Pharma GmbH Am Windfeld 35 83714 Miesbach DEUTSCHLAND EU/1/09/547/001-007 Film-coated tablet B01AC-04 23.9.2009 21.9.2009 Vizarsin Sildenafil KRKA, d.d. Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto SLOVENIJA EU/1/09/551/001-012 Film-coated tablet G04B E03 23.9.2009 21.9.2009 Clopidogrel DURA Clopidogrel Mylan dura GmbH Wittichstraße 6 64295 Darmstadt DEUTSCHLAND EU/1/09/560/001-009 Film-coated tablet B01AC-04 23.9.2009 21.9.2009 Clopidogrel HCS Clopidogrel HCS bvba H. Kennisstraat 53 2650 Edegem BELGÏE EU/1/09/561/001-009 Film-coated tablet V03AC02 23.9.2009 21.9.2009 Topotecan Teva Topotecan Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND EU/1/09/552/001-004 Concentrate for solution for infusion L01XX17 23.9.2009 21.9.2009 Zopya Clopidogrel Norpharm Regulatory Services Ltd. 26 Laurence Street Drogheda Co. Louth IRELAND EU/1/09/562/001-009 Film-coated tablet B01AC-04 23.9.2009 21.9.2009 Zylagren Clopidogrel KRKA, d.d. Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto SLOVENIJA EU/1/09/558/001-010 Film-coated tablet B01AC-04 23.9.2009 21.9.2009 Clopidogrel Mylan Clopidogrel Mylan S.A.S 117 Allée des Parcs 69800 Saint Priest FRANCE EU/1/09/559/001-009 Film-coated tablet B01AC-04 23.9.2009 21.9.2009 Javlor Vinflunine ditartrate Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne FRANCE EU/1/09/550/001-012 Concentrate for solution for infusion L01CA05 23.9.2009 21.9.2009 Clopidogrel Acino Pharma GmbH Clopidogrel Acino Pharma GmbH Am Windfeld 35 83714 Miesbach DEUTSCHLAND EU/1/09/548/001-007 Film-coated tablet B01AC-04 23.9.2009 23.9.2009 Clopidogrel TAD Clopidogrel TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven DEUTSCHLAND EU/1/09/555/001-009 Film-coated tablet B01AC-04 25.9.2009 23.9.2009 Clopidogrel Krka Clopidogrel KRKA, d.d. Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto SLOVENIJA EU/1/09/556/001-009 Film-coated tablet B01AC-04 25.9.2009 23.9.2009 Clopidogrel Qualimed Clopidogrel Qualimed 117 Allée des Parcs 69800 Saint Priest FRANCE EU/1/09/557/001-009 Film-coated tablet B01AC-04 25.9.2009 23.9.2009 Clopidogrel ratiopharm Clopidogrel Acino Pharma GmbH Am Windfeld 35 83714 Miesbach DEUTSCHLAND EU/1/09/554/001-007 Film-coated tablet B01AC-04 25.9.2009 28.9.2009 Clopidogrel Acino Pharma Clopidogrel Acino Pharma GmbH Am Windfeld 35 83714 Miesbach DEUTSCHLAND EU/1/09/549/001-007 Film-coated tablet B01AC-04 30.9.2009 28.9.2009 Zyllt Clopidogrel KRKA, d.d. Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto SLOVENIJA EU/1/09/553/001-010 Film-coated tablet B01AC-04 30.9.2009

— 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 2.9.2009 Zomarist Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/08/483/001-018 7.9.2009 2.9.2009 Keppra UCB Pharma SA. Allée de la Recherche/Researchdreef 60 1070 Bruxelles/Brussel BELGIQUE/BELGIË EU/1/00/146/001-032 7.9.2009 2.9.2009 Inovelon Eisai Limited European Knowledge Centre Mosquito Way Hatfield Herts AL10 9SN UNITED KINGDOM EU/1/06/378/001-016 7.9.2009 2.9.2009 Lumigan Allergan Pharmaceuticals Ireland Castlebar Road Westport Co. Mayo IRELAND EU/1/02/205/001-002 7.9.2009 2.9.2009 Norvir Abbott Laboratories Ltd. Queenborough Kent ME11 5EL UNITED KINGDOM EU/1/96/016/001 EU/1/96/016/003-004 7.9.2009 2.9.2009 Silgard Merck Sharp & Dohme Ltd. Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/06/358/001-021 7.9.2009 4.9.2009 Zevalin Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND EU/1/03/264/001 7.9.2009 4.9.2009 Prialt Eisai Limited European Knowledge Centre Mosquito Way Hatfield Herts AL10 9SN UNITED KINGDOM EU/1/04/302/001-004 7.9.2009 7.9.2009 Sebivo Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/388/001-003 9.9.2009 9.9.2009 Isentress Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/07/436/001-002 15.9.2009 9.9.2009 Tamiflu Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/02/222/001-004 15.9.2009 14.9.2009 Avaglim SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS UNITED KINGDOM EU/1/06/349/001-010 15.9.2009 16.9.2009 Efficib Merck Sharp & Dohme Ltd. Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/457/001-016 18.9.2009 16.9.2009 Velmetia Merck Sharp & Dohme Ltd. Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/456/001-016 18.9.2009 16.9.2009 Janumet Merck Sharp & Dohme Ltd. Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/455/001-016 18.9.2009 17.9.2009 Ribavirin Teva Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND EU/1/09/509/001-004 21.9.2009 17.9.2009 Lantus Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND EU/1/00/134/001-037 21.9.2009 17.9.2009 Actos Takeda Global Research and Development Centre (Europe) Ltd. 61 Aldwych London WC2B 4AE UNITED KINGDOM EU/1/00/150/001-024 21.9.2009 17.9.2009 Glustin Takeda Global Research and Development Centre (Europe) Ltd. 61 Aldwych London WC2B 4AE UNITED KINGDOM EU/1/00/151/001-024 21.9.2009 17.9.2009 Optisulin Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND EU/1/00/133/001-032 21.9.2009 17.9.2009 Doribax Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË EU/1/08/467/001 21.9.2009 17.9.2009 Duloxetine Boehringer Ingelheim Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/08/471/001-012 21.9.2009 17.9.2009 Glubrava Takeda Global Research and Development Centre (Europe) Ltd. 61 Aldwych London WC2B 4AE UNITED KINGDOM EU/1/07/421/001-009 21.9.2009 21.9.2009 Orfadin Swedish Orphan International AB Drottninggatan 98 SE-111 60 Stockholm SVERIGE EU/1/04/303/001-003 23.9.2009 21.9.2009 Elaprase Shire Human Genetic Therapies AB Svärdvägen 11D SE-182 33 Danderyd SVERIGE EU/1/06/365/001-003 23.9.2009 21.9.2009 Alimta Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/04/290/001-002 23.9.2009 21.9.2009 Ferriprox Apotex Europe B.V. Darwingweg 20 2333 CR Leiden NEDERLAND EU/1/99/108/001-003 23.9.2009 21.9.2009 Azilect Teva Pharma GmbH Kandelstrasse 10 79199 Kirchzarten DEUTSCHLAND EU/1/04/304/001-007 23.9.2009 21.9.2009 Trisenox Cephalon Europe 5 Rue Charles Martigny 94700 Maisons Alfort, Cedex FRANCE EU/1/02/204/001 23.9.2009 23.9.2009 Mimpara Amgen Europe B.V. Minervum 7061 4817 ZK Breda NEDERLAND EU/1/04/292/001-012 25.9.2009 24.9.2009 Emselex Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/04/294/001-028 28.9.2009 25.9.2009 Qutenza Astellas Pharma Europe B.V. Elisabethhof 19 2353 EW Leiderdorp NEDERLAND NeurogesX UK Limited 265 Strand London WC2R 1BH UNITED KINGDOM EU/1/09/524/001-002 29.9.2009 29.9.2009 Focetria Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina 1 Siena SI ITALIA EU/1/07/385/001-004 30.9.2009 29.9.2009 Pandemrix GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/08/452/001 30.9.2009

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

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 14.9.2009 Lyrica Pfizer Ltd. Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/04/279/001-043 16.9.2009

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

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 2.9.2009 Tekturna Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/408/001-020 7.9.2009

— Issuing of a marketing authorisation authorisation (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 authorisation Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 23.9.2009 Palladia Toceranib Pfizer Ltd. Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/2/09/100/001-003 Tablets QL01XE91 25.9.2009

— 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 2.9.2009 Cerenia Pfizer Ltd. Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/2/06/062/001-003 EU/2/06/062/005 7.9.2009 8.9.2009 Posatex Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND EU/2/08/081/001-003 10.9.2009

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.