EN Official Journal of the European Union C 22/18

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2009 to 31 December 2009

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

2010/C 22/04

— 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 3.12.2009 Olanzapine Glenmark Europe Olanzapine Glenmark Generics (Europe) Limited Laxmi House 2-B Draycott Avenue Kenton Harrow Middlesex HA3 OBU UNITED KINGDOM EU/1/09/588/001-017 Orodispersible tablet N05AH03 7.12.2009 3.12.2009 Olanzapine Glenmark Olanzapine Glenmark Generics (Europe) Limited Laxmi House 2-B Draycott Avenue Kenton Harrow Middlesex HA3 OBU UNITED KINGDOM EU/1/09/587/001-012 Tablet N05AH03 7.12.2009 9.12.2009 Prevenar 13 Pneumococcalpolysaccharide conjugate vaccine (13-valent, adsorbed) Wyeth Lederle Vaccines S.A. Rue du Bosquet 15 1348 Louvain-la-Neuve BELGIQUE EU/1/09/590/001-006 Suspension for injection J07AL02 11.12.2009 10.12.2009 Lamivudine Teva Pharma B.V Lamivudine Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND EU/1/09/596/001-014 Film-coated tablet J05AF05 14.12.2009 10.12.2009 Olazax Disperzi Olanzapine Glenmark Pharmaceuticals s.r.o City Tower Hvězdova 1716/2b 140 78 Praha 4 ČESKÁ REPUBLIKA EU/1/09/592/001-005 Orodispersible tablet N05AH03 14.12.2009 10.12.2009 Sildenafil Actavis Sildenafil Actavis Group PTC ehf. Reykjavikurvegi 76-78 220 Hafnarfjordur ICELAND EU/1/09/595/001-015 Film-coated tablet G04BE03 14.12.2009 11.12.2009 Olazax Olanzapine Glenmark Pharmaceuticals s.r.o. City Tower Hvězdova 1716/2b 140 78 Praha 4 ČESKÁ REPUBLIKA EU/1/09/597/001-005 Tablet N05AH03 15.12.2009 11.12.2009 Rivastigmine Hexal Rivastigmine HEXAL AG Industriestrasse 25 83607 Holzkirchen DEUTSCHLAND EU/1/09/589/001-016 EU/1/09/589/017-018 Capsule, hard Oral solution N06DA03 15.12.2009 11.12.2009 Rivastigmine Sandoz Rivastigmine Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11 83607 Holzkirchen DEUTSCHLAND EU/1/09/599/001-016 EU/1/09/599/017-018 Capsule, hard Oral solution N06DA03 15.12.2009 23.12.2009 Zenas Amifampridine EUSA Pharma SAS 3 allée des Séquoias 69760 Limonest FRANCE EU/1/09/601/001 Tablet N07XX05 28.12.2009 23.12.2009 Sildenafil ratiopharm Sildenafil Ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm DEUTSCHLAND EU/1/09/603/001-012 Film-coated tablet G04BE03 28.12.2009

— 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 3.12.2009 Champix Pfizer Ltd. Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/06/360/001-013 7.12.2009 3.12.2009 Rasilez Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/405/001-040 7.12.2009 8.12.2009 Xigiris Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/02/225/001-002 10.12.2009 8.12.2009 Renagel Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND EU/1/99/123/005-013 10.12.2009 9.12.2009 Stocrin Merck Sharp & Dohme Ltd. Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/99/111/001-005 EU/1/99/111/008-011 11.12.2009 9.12.2009 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/99/110/001-005 EU/1/99/110/008-010 11.12.2009 9.12.2009 Pandemrix GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/08/452/001 11.12.2009 10.12.2009 Effentora Cephalon Europe 5 rue Charles Martigny 94700 Maisons-Alfort FRANCE EU/1/08/441/001-010 14.12.2009 10.12.2009 Effentora Cephalon Europe 5 rue Charles Martigny 94700 Maisons-Alfort FRANCE EU/1/08/441/001-010 14.12.2009 10.12.2009 Synflorix GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/09/508/001-010 14.12.2009 10.12.2009 Truvada Gilead Sciences International Limited Cambridge CB21 6GT UNITED KINGDOM EU/1/04/305/001-002 14.12.2009 10.12.2009 Fendrix GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/04/299/001-003 14.12.2009 10.12.2009 EVOLTRA Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND EU/1/06/334/001-005 14.12.2009 10.12.2009 Revatio Pfizer Limited Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/05/318/002 24.12.2009 11.12.2009 Kivexa Glaxo Group Ltd. Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/04/298/001-003 16.12.2009 11.12.2009 Clopidogrel Mylan Pharma Apotex Europe B.V. Darwingweg 20 2333 CR Leiden NEDERLAND Mylan S.A.S. 117 allée des Parcs 69800 Saint Priest FRANCE EU/1/09/568/001-018 16.12.2009 11.12.2009 Rivastigmine 1A Pharma 1A Pharma GmbH Keltenring 1+3 82041 Oberhaching DEUTSCHLAND EU/1/09/585/001-018 16.12.2009 11.12.2009 EVICEL OMRIX biopharmaceuticals S.A./N.V. Chaussée de Waterloo/Waterloosesteenweg 200 1640 Rhode-St-Genèse/Sint-Genesius-Rode BELGIQUE/BELGIË EU/1/08/473/001-003 15.12.2009 11.12.2009 Abseamed Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 58638 Iserlohn DEUTSCHLAND EU/1/07/412/001-020 15.12.2009 14.12.2009 Efient Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/08/503/001-016 16.12.2009 14.12.2009 Exalief BIAL-Portela & Ca, SA A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado PORTUGAL EU/1/09/520/001-020 17.12.2009 14.12.2009 Zebinix BIAL-Portela & Ca, SA A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado PORTUGAL EU/1/09/514/001-020 17.12.2009 16.12.2009 REVLIMID Celgene Europe Limited Riverside House Riverside Walk Windsor Berkshire SL4 1NA UNITED KINGDOM EU/1/07/391/001-004 18.12.2009 18.12.2009 Docetaxel Winthrop Aventis Pharma S.A. 20 avenue Raymond Aron 92165 Antony Cedex FRANCE EU/1/07/384/001-004 22.12.2009 18.12.2009 Emtriva Gilead Sciences International Limited Cambridge CB21 6GT UNITED KINGDOM EU/1/03/261/003 22.12.2009 18.12.2009 Adenuric Ipsen Pharma 65 quai Georges Gorse 92100 Boulogne-Billancourt FRANCE Menarini International Operations Luxembourg S.A. 1, avenue de la Gare 1611 Luxembourg LUXEMBOURG EU/1/08/447/001-004 22.12.2009 18.12.2009 Aloxi Helsinn Birex Pharmaceuticals Ltd. Damastown Mulhuddart Dublin 15 IRELAND EU/1/04/306/001 22.12.2009 16.12.2009 Binocrit Sandoz GmbH Biochemiestraße 10 6250 Kundl ÖSTERREICH EU/1/07/410/001-026 18.12.2009 16.12.2009 Epoetin alfa hexal Hexal AG. Industriestraße 25 83607 Holzkirchen DEUTSCHLAND EU/1/07/411/001-026 21.12.2009 16.12.2009 Silapo STADA Arzneimittel AG Stadastraße 2—18 61118 Bad Vilbel DEUTSCHLAND EU/1/07/432/001-022 18.12.2009 18.12.2009 Litak Lipomed GmbH Hegenheimer Straße 2 79576 Weil/Rhein DEUTSCHLAND EU/1/04/275/001-002 22.12.2009 21.12.2009 AZARGA Alcon Laboratories (UK) Ltd. Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD UNITED KINGDOM EU/1/08/482/001-002 23.12.2009 21.12.2009 Altargo Glaxo Group Limited Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/07/390/001-004 24.12.2009 21.12.2009 Zyprexa Velotab Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/99/125/001-016 23.12.2009 21.12.2009 Avastin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/04/300/001-002 23.12.2009 21.12.2009 LYRICA Pfizer Ltd. Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/04/279/001-043 24.12.2009 21.12.2009 Taxotere Aventis Pharma S.A. 20 avenue Raymond Aron 92165 Antony Cedex FRANCE EU/1/95/002/001-004 23.12.2009 21.12.2009 Zyprexa Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/96/022/002 EU/1/96/022/004 EU/1/96/022/006 EU/1/96/022/009-012 EU/1/96/022/014 EU/1/96/022/016-017 EU/1/96/022/019-034 23.12.2009 21.12.2009 Revasc Canyon Pharmaceuticals Ltd. 20-22 Bedford Row London WC1R 4JS UNITED KINGDOM EU/1/97/043/001-003 11.1.2010 21.12.2009 RAPAMUNE Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/01/171/001 EU/1/01/171/007-010 23.12.2009 21.12.2009 SOLIRIS Alexion Europe S.A.S. 25 Boulevard de l'Amiral Bruix 75016 Paris FRANCE EU/1/07/393/001 23.12.2009 21.12.2009 Vimpat UCB Pharma SA. Allée de la Recherche 66/Researchdreef 60 1070 Bruxelles/Brussel BELGIQUE/BELGIË EU/1/08/470/001-017 28.12.2009 21.12.2009 ZONEGRAN Eisai Limited European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN UNITED KINGDOM EU/1/04/307/001-013 24.12.2009 21.12.2009 ZYPADHERA Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/08/479/001-003 23.12.2009 21.12.2009 Agenerase Glaxo Group Limited Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/00/148/001-004 23.12.2009 21.12.2009 Irbesartan HCT Winthrop Sanofi Pharma Bristol Myers Squibb SNC 174 avenue de France 75013 Paris FRANCE EU/1/06/377/001-028 23.12.2009 21.12.2009 KARVEZIDE Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/98/085/001-034 23.12.2009 21.12.2009 Tevagrastim Teva Generics GmbH Wasastraße 50 01445 Radebeul DEUTSCHLAND EU/1/08/445/001-014 23.12.2009 21.12.2009 Avamys Glaxo Group Ltd. Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/07/434/001-003 24.12.2009 21.12.2009 Thelin Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ UNITED KINGDOM EU/1/06/353/001-005 24.12.2009 21.12.2009 Volibris Glaxo Group Ltd. Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/08/451/001-004 24.12.2009 22.12.2009 CELVAPAN Baxter AG Industriestraße 67 1221 Wien ÖSTERREICH EU/1/08/506/001 23.12.2009 22.12.2009 Pandemrix GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/08/452/001 23.12.2009 22.12.2009 Stelara Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË EU/1/08/494/001-002 24.12.2009 22.12.2009 Tasigna Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/422/001-004 24.12.2009 22.12.2009 Replagal Shire Human Genetic Therapies AB Svärdvägen 11D SE-182 33 Danderyd SVERIGE EU/1/01/189/001-006 28.12.2009 22.12.2009 Evra Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË EU/1/02/223/001-003 24.12.2009 22.12.2009 Crixivan Merck Sharp & Dohme Ltd. Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/96/024/001-005 EU/1/96/024/008 EU/1/96/024/010 24.12.2009 22.12.2009 Onsior Novartis Animal Health UK Ltd. Frimley Business Park Frimley/Camberley Surrey GU16 7SR UNITED KINGDOM EU/2/08/089/001-021 24.12.2009 22.12.2009 RELISTOR Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/08/463/001-003 24.12.2009 23.12.2009 Tractocile Ferring Pharmaceuticals A/S Kay Fiskers Plads 11 2300 Copenhagen S DANMARK EU/1/99/124/001-002 28.12.2009 23.12.2009 Biograstim CT Arzneimittel GmbH Lengeder Straße 42a 13407 Berlin DEUTSCHLAND EU/1/08/450/001-010 29.12.2009 23.12.2009 Retacrit HOSPIRA Enterprises B.V. Taurusavenue 19-21b 2132 LS Hoofddorp NEDERLAND EU/1/07/431/001-025 31.12.2009 23.12.2009 TORISEL Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/07/424/001 4.1.2010 23.12.2009 IVEMEND Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/07/437/001-002 4.1.2010 23.12.2009 Alisade Glaxo Group Ltd, Greenford Middlesex UB6 ONN UNITED KINGDOM EU/1/08/474/001-003 4.1.2010 23.12.2009 Focetria Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina 1 Siena SI ITALIA EU/1/07/385/001-002 EU/1/07/385/004 28.12.2009

— 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 14.12.2009 Aivlosin ECO Animal Health Ltd. 78 Coombe Road New Malden Surrey KT3 4QS UNITED KINGDOM EU/2/04/044/011-012-013 16.12.2009 18.12.2009 Equioxx MERIAL 29 avenue Tony Garnier 69007 Lyon FRANCE EU/2/08/083/002-003 22.12.2009 21.12.2009 Flexicam Dechra Veterinary Products A/S Mekuvej 9 7171 Uldum DANMARK Omnipharm Ltd. The Spire Egypt Road Nottingham NG7 7GD UNITED KINGDOM EU/2/06/058/001-004 23.12.2009

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.