EN Official Journal of the European Union C 330/6

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 November 2008 to 30 November 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 330/06)

— 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 19.11.2008 Zypadhera Olanzapine Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA, Houten Nederland EU/1/08/479/001-003 Powder and solvent for prolonged release suspension for injection N05A H03 24.11.2008 19.11.2008 Jalra Vildagliptin Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/08/485/001-011 Tablet A10BH02 21.11.2008 19.11.2008 Xiliarx Vildagliptin Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/08/486/001-011 Tablet A10BH02 21.11.2008 25.11.2008 Azarga Brinzolamide/timolol Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom EU/1/08/482/001-002 Eye drops, suspension S01ED51 27.11.2008

— 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 4.11.2008 Insuman Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/97/030/028-169 18.11.2008 4.11.2008 Velcade Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/04/274/001-002 6.11.2008 4.11.2008 Tractocile Ferring Pharmaceuticals A/S Kay Fiskers Plads 11 DK-2300 Copenhagen S Ferring AB Soldattorpsvägen 5 Box 30 047 S-20061 Limhamn EU/1/99/124/001-002 6.11.2008 4.11.2008 Refludan Celgene Europe Ltd Riverside House Riverside Walk Windsor Berks SL4 1NA United Kingdom Pharmion Limited Riverside House Riverside Walk Windsor SL4 1NA United Kingdom EU/1/97/035/001-004 6.11.2008 6.11.2008 Neupro Schwarz Pharma Ltd Shannon Industrial Estate Co.Clare Ireland EU/1/05/331/001-037 11.11.2008 19.11.2008 Atriance Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom EU/1/07/403/001 21.11.2008 19.11.2008 Kinzalmono Bayer HealthCare AG D-51368 Leverkusen EU/1/98/091/001-014 21.11.2008 19.11.2008 Isentress Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/07/436/001-002 21.11.2008 19.11.2008 Micardis Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/98/090/001-020 21.11.2008 19.11.2008 Pritor Bayer HealthCare AG D-51368 Leverkusen EU/1/98/089/001-022 21.11.2008 20.11.2008 Diacomit Biocodex 7, avenue Gallieni F-94250 Gentilly EU/1/06/367/001-012 24.11.2008 20.11.2008 Increlex Tercica Europe Limited Riverside One Sir John Rogerson's Quay Dublin 2 Ireland EU/1/07/402/001 24.11.2008 20.11.2008 Kineret Biovitrum AB (publ) S-112 76 Stockholm Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/02/203/001-004 24.11.2008 20.11.2008 Kepivance Biovitrum AB (publ) S-112 76 Stockholm Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/05/314/001 24.11.2008 20.11.2008 Revlimid Celgene Europe Limited Riverside House Riverside Walk Windsor Berkshire SL4 1NA United Kingdom EU/1/07/391/001-004 24.11.2008 21.11.2008 Olanzapine Teva Teva Pharma B.V. Computerweg 10 DR Utrecht 3542 Nederland EU/1/07/427/001-057 25.11.2008 21.11.2008 Olanzapine Neopharma Neopharma Limited 57 High Street Odiham Hampshire RG29 1LF United Kingdom EU/1/07/426/001-011 25.11.2008 21.11.2008 Retacrit HOSPIRA Enterprises B.V. Taurusavenue 19-21b 2132 LS Hoofddorp Nederland EU/1/07/431/001-025 25.11.2008 21.11.2008 Binocrit Sandoz GmbH Biochemiestraße 10 A-Kundl 6250 EU/1/07/410/001-020 25.11.2008 21.11.2008 Abseamed Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 D-58638 Iserlohn EU/1/07/412/001-020 25.11.2008 21.11.2008 Epoetin alfa Hexal HEXAL Biotech Forschungs GmbH Industriestraße 25 D-83607 Holzkirchen EU/1/07/411/001-020 26.11.2008 24.11.2008 Mabthera Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/98/067/001-002 26.11.2008 24.11.2008 Myocet Cephalon Europe 5, rue Charles Martigny F-94700 Maisons Alfort EU/1/00/141/001 26.11.2008 24.11.2008 Erbitux Merck KgaA Frankfurter Straße 250 D-64271 Darmstadt EU/1/04/281/001-005 26.11.2008 24.11.2008 Lucentis Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/374/001 26.11.2008 24.11.2008 Kaletra Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/01/172/001-006 27.11.2008 24.11.2008 Silapo STADA Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vilbel EU/1/07/432/001-022 26.11.2008 25.11.2008 Avonex Biogen Idec Ltd Innovation House 70 Norden Road Maidenhead Berkshire SL6 4AY United Kingdom EU/1/97/033/002-004 27.11.2008 25.11.2008 Prezista Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/06/380/001 27.11.2008 25.11.2008 Champix Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/06/360/001-012 27.11.2008 25.11.2008 Raptiva Serono Europe Limited 56 Marsh Wall London E14 9TP United Kingdom EU/1/04/291/001-003 27.11.2008 25.11.2008 Luminity Bristol-Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe B-1170 Bruxelles EU/1/06/361/001-002 27.11.2008 25.11.2008 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom EU/1/04/295/001 27.11.2008 25.11.2008 Temodal Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel EU/1/98/096/001-012 27.11.2008 25.11.2008 Docetaxel Winthrop Aventis Pharma S.A 20, avenue Raymond Aron F-92160 Antony EU/1/07/384/001-002 27.11.2008 25.11.2008 Nexavar Bayer HealthCare AG D-51368 Leverkusen EU/1/06/342/001 27.11.2008 26.11.2008 Cervarix GlaxoSmithKline Biologicals S.A. rue de l'Institut, 89 B-1330 Rixensart EU/1/07/419/001-012 28.11.2008 26.11.2008 Atripla Bristol-Myers Squibb and Gilead Sciences Limited Unit 13 Stillorgan Industrial Park Blackrock Co. Dublin Ireland EU/1/07/430/001-002 28.11.2008 26.11.2008 Cancidas Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/01/196/001-003 28.11.2008 26.11.2008 Taxotere Aventis Pharma S.A. 20, avenue Raymond Aron F-92165 Antony Cedex EU/1/95/002/001-002 28.11.2008 26.11.2008 Zalasta KRKA d.d. Šmarješka cesta 6 SLO-8501 Novo mesto EU/1/07/415/001-056 28.11.2008 28.11.2008 Stocrin Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/99/111/001-011 2.12.2008 28.11.2008 Vistide Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom Pfizer Enterprises SARL 51, avenue Kennedy Rond Point du Kirchberg L-1855 Luxembourg EU/1/97/037/001 2.12.2008 28.11.2008 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/00/134/012 2.12.2008 28.11.2008 Optisulin Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/00/133/008 2.12.2008 28.11.2008 Pegasys Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/221/001-010 2.12.2008 28.11.2008 Toviaz Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom EU/1/07/386/001-016 2.12.2008

— Suspension of a marketing authorization (Article 20 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 13.11.2008 Zimulti Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/06/345/001-011 17.11.2008 13.11.2008 Acomplia Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/06/344/001-011 17.11.2008

— 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 17.11.2008 Masivet Masitinib AB Science S.A. 3, avenue George V F-75008 Paris EU/2/08/087/001-002 Film-coated tablet QL01XE90 19.11.2008 20.11.2008 Easotic Hydrocortisone aceponate, miconazole nitrate, gentamicin sulphate VIRBAC S.A. 1ère avenue 2065 m L.I.D. F-06516 Carros EU/2/08/085/001 Ear drops, suspension QS02CA03 24.11.2008 21.11.2008 Duvaxyn WNV Inactivated West Nile Virus, strain VM-2 Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH United Kingdom EU/2/08/086/001-003 Emulsion for injection QI05AA10 25.11.2008

— 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 18.11.2008 Cerenia Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/2/06/062/005 20.11.2008 20.11.2008 Nobilis Influenza Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/06/061/001-004 24.11.2008

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.