EN Official Journal of the European Union C 101/3

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2009 to 31 March 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 101/03

— 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 4.3.2009 CELVAPAN Pandemic influenza vaccine (H5N1 whole virion, Vero cell derived, inactivated) Baxter AG Industriestraße 67 A - 1221 Wien ÖSTERREICH EU/1/08/506/001 Suspension for injection J07BB01 6.3.2009 6.3.2009 MEPACT mifamurtide IDM Pharma S.A. 47 rue de Chaillot 75116 Paris FRANCE EU/1/08/502/001 Powder for suspension for infusion L03AX15 23.3.2009 19.3.2009 Fertavid follitropin beta SP Europe Rue de Stalle 73 B-1180 Bruxelles BELGIQUE EU/1/09/510/001-019 Solution for injection G03G A06 23.3.2009 30.3.2009 Synflorix Pneumococcal polysaccharide conjugate vaccine (adsorbed) GlaxoSmithKline Biologicals S.A. rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/09/508/001-009 Suspension for injection J07AL52 31.3.2009 31.3.2009 Ribavirin Teva Ribavirin Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND EU/1/09/509/001-004 Capsule, hard J05A B04 2.4.2009 31.3.2009 IXIARO Japanese Encephalitis vaccine (inactivated, adsorbed) Intercell AG Campus Vienna Biocenter 3 A-1030 Wien ÖSTERREICH EU/1/08/501/001-002 Suspension for injection J07BA02 2.4.2009

— 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 2.3.2009 Fendrix GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 Rixensart, B-1330 BELGIQUE EU/1/04/299/001-003 4.3.2009 2.3.2009 Cymbalta Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/04/296/001-009 4.3.2009 2.3.2009 Fareston Orion Corporation Orionintie 1 FIN-02200 Espoo SUOMI EU/1/96/004/001-002 4.3.2009 2.3.2009 Nexavar Bayer HealthCare AG D-51368 Leverkusen DEUTSCHLAND EU/1/06/342/001 4.3.2009 2.3.2009 Irbesartan BMS Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/06/375/001-033 4.3.2009 2.3.2009 Aptivus Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/05/315/001 4.3.2009 2.3.2009 Ganfort Allergan Pharmaceuticals Ireland Castlebar Road Westport, Co. Mayo IRELAND EU/1/06/340/001-002 5.3.2009 4.3.2009 KOGENATE Bayer Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND EU/1/00/143/001-011 6.3.2009 4.3.2009 Helixate NexGen Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND EU/1/00/144/001-004 6.3.2009 4.3.2009 Gardasil Sanofi Pasteur MSD SNC, 8, rue Jonas Salk 69007 Lyon FRANCE EU/1/06/357/001-021 6.3.2009 4.3.2009 Cystadane Orphan Europe S.a.r.l. Immeuble Le Wilson 70 Avenue du Général de Gaulle 92800 Puteaux FRANCE EU/1/06/379/001 6.3.2009 4.3.2009 Photobarr Axcan Pharma International BV Engelenkampstraat 72 6131 JJ Sittard NEDERLAND EU/1/04/272/001-002 6.3.2009 6.3.2009 Silgard Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/06/358/001-021 10.3.2009 6.3.2009 BYETTA Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/06/362/001-004 10.3.2009 6.3.2009 IntronA Schering Plough Europe Rue de Stalle, 73 1180 Bruxelles BELGIQUE EU/1/99/127/001-044 10.3.2009 6.3.2009 Remicade Centocor B.V. Einsteinweg 101 2333 CB Leiden NEDERLAND EU/1/99/116/001-005 10.3.2009 6.3.2009 Protelos Les Laboratoires Servier 22, rue Garnier 92200 Neuilly-sur-Seine FRANCE EU/1/04/288/001-006 10.3.2009 6.3.2009 ATryn LEO Pharma A/S Industriparken 55 DK-2750 Ballerup DANMARK EU/1/06/355/001-003 10.3.2009 6.3.2009 Irbesartan Hydrochlorothiazide Winthrop SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174 avenue de France F- 75013 Paris FRANCE EU/1/06/377/001-028 10.3.2009 9.3.2009 Optisulin Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main DEUTSCHLAND EU/1/00/133/001-032 11.3.2009 9.3.2009 Osseor Les Laboratoires Servier 22, rue Garnier 92200 Neuilly-sur-Seine FRANCE EU/1/04/287/001-006 11.3.2009 9.3.2009 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/99/110/001-009 11.3.2009 10.3.2009 DULOXETINE BOEHRINGER INGELHEIM Boehringer Ingelheim International GmbH Binger Strasse 173 - D - 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/08/471/001-012 12.3.2009 17.3.2009 Pritor Plus Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND EU/1/02/215/001-021 19.3.2009 17.3.2009 Irbesartan Winthrop SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174 avenue de France F- 75013 Paris FRANCE EU/1/06/376/001-033 19.3.2009 17.3.2009 Pritor Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND EU/1/98/089/001-022 19.3.2009 17.3.2009 Hycamtin SmithKline Beecham plc 980 Great West Road, Brentford Middlesex,TW8 9GS UNITED KINGDOM EU/1/96/027/001 EU/1/96/027/003-007 19.3.2009 17.3.2009 Onsenal Pfizer Limited Ramsgate Road, Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/03/259/001-006 19.3.2009 18.3.2009 Irbesartan HCT BMS Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/06/369/001-028 20.3.2009 18.3.2009 Atriance Glaxo Group Limited Berkeley Avenue, Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/07/403/001 20.3.2009 18.3.2009 Kinzalkomb Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND EU/1/02/214/001-015 20.3.2009 18.3.2009 MicardisPlus Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/02/213/001-023 20.3.2009 18.3.2009 Kinzalmono Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND EU/1/98/091/001-014 20.3.2009 19.3.2009 Regranex Janssen-Cilag International NV Turnhoutseweg 30 - 2340 Beerse – BELGIË EU/1/99/101/001 23.3.2009 19.3.2009 Stalevo Orion Corporation Orionintie 1 FIN-02200 Espoo SUOMI EU/1/03/260/001-023 23.3.2009 19.3.2009 Micardis Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/98/090/001-020 23.3.2009 19.3.2009 Vectibix Amgen Europe B.V. Minervum 7061 NL-4817 ZK Breda NEDERLAND EU/1/07/423/001-003 23.3.2009 23.3.2009 NovoSeven Novo Nordisk A/S Novo Allé DK-2880 Bagsvaerd DANMARK EU/1/96/006/001-003 25.3.2009 23.3.2009 Irbesartan BMS Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/06/375/001-033 25.3.2009 25.3.2009 Avastin Roche Registration Limited 6 Falcon Way, Shire Park Welwyn Garden City, AL7 1TW UNITED KINGDOM EU/1/04/300/001-002 27.3.2009 25.3.2009 Enbrel Wyeth Europa Limited Huntercombe Lane South, Taplow Maidenhead, Berkshire, SL6 0PH UNITED KINGDOM EU/1/99/126/001-018 27.3.2009 25.3.2009 Telzir Glaxo Group Ltd. Greenford Road, Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/04/282/001-002 27.3.2009 25.3.2009 Ariclaim Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/04/283/001-012 27.3.2009 25.3.2009 Exjade Novartis Europharm Limited Wimblehurst Road, Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/06/356/001-009 27.3.2009 25.3.2009 Arixtra Glaxo Group Ltd. Greenford Road, Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/02/206/001-035 27.3.2009 25.3.2009 Xenical Roche Registration Limited 6 Falcon Way, Shire Park Welwyn Garden City, AL7 1TW UNITED KINGDOM EU/1/98/071/001-006 27.3.2009 25.3.2009 Cymbalta Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/04/296/001-009 27.3.2009 25.3.2009 Advagraf Astellas Pharma Europe B.V. Elisabethhof 19 NL-2353 EW Leiderdorp NEDERLAND EU/1/07/387/001-010 27.3.2009 25.3.2009 Pradaxa Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein DEUTSCHLAND EU/1/08/442/001-008 27.3.2009 25.3.2009 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/1/96/022/008-012 EU/1/96/022/014 EU/1/96/022/016-017 EU/1/96/022/019-034 27.3.2009 25.3.2009 ProQuad Sanofi Pasteur MSD SNC, 8, rue Jonas Salk 69007 Lyon FRANCE EU/1/05/323/001-013 27.3.2009 25.3.2009 Cetrotide Serono Europe Limited 56, Marsh Wall London E14 9TP UNITED KINGDOM EU/1/99/100/001-003 27.3.2009 25.3.2009 Tyverb Glaxo Group Limited Berkeley Avenue, Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/07/440/001-002 27.3.2009 25.3.2009 Lysodren Laboratoire HRA Pharma 15, rue Béranger 75003 Paris FRANCE EU/1/04/273/001 27.3.2009 25.3.2009 Zyprexa Velotab Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/99/125/001-016 27.3.2009 25.3.2009 Yondelis Pharma Mar, S.A. Avda. de los Reyes 1 Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) ESPAÑA EU/1/07/417/001-002 27.3.2009 25.3.2009 Extavia Novartis Europharm Limited Wimblehurst Road, Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/08/454/001-002 EU/1/08/454/005 27.3.2009 25.3.2009 Mabthera Roche Registration Limited 6 Falcon Way, Shire Park Welwyn Garden City, AL7 1TW UNITED KINGDOM EU/1/98/067/001-002 27.3.2009 25.3.2009 Beromun Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/99/097/001 27.3.2009 25.3.2009 Dukoral SBL Vaccin AB S-105 21 Stockholm SWEDEN EU/1/03/263/001-003 30.3.2009 25.3.2009 NeuroBloc Eisai Limited 3, Shortlands London W6 8EE UNITED KINGDOM EU/1/00/166/001-003 30.3.2009 25.3.2009 Xeristar Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/04/297/001-008 27.3.2009 27.3.2009 Aerinaze SP Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel BELGIË EU/1/07/399/001-006 1.4.2009 27.3.2009 Liprolog Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/01/195/001-015 EU/1/01/195/022-025 1.4.2009 27.3.2009 Karvezide Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/98/085/001-034 1.4.2009 27.3.2009 Irbesartan HCT Winthrop SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174 avenue de France F- 75013 Paris FRANCE EU/1/06/377/001-028 1.4.2009 27.3.2009 Litak Lipomed GmbH Schönaugasse 11 D-79713 Bad Säckingen DEUTSCHLAND EU/1/04/275/001-002 1.4.2009 27.3.2009 Procoralan Les Laboratoires Servier 22, rue Garnier 92200 Neuilly-sur-Seine FRANCE EU/1/05/316/001-014 1.4.2009 27.3.2009 Mimpara Amgen Europe B.V. Minervum 7061 NL-4817 ZK Breda NEDERLAND EU/1/04/292/001-012 1.4.2009 27.3.2009 TRIZIVIR Glaxo Group Ltd. Greenford Road, Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/00/156/002-003 1.4.2009 27.3.2009 Dafiro Novartis Europharm Limited Wimblehurst Road, Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/06/371/001-036 1.4.2009 27.3.2009 Copalia Novartis Europharm Limited Wimblehurst Road, Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/06/372/001-036 1.4.2009 27.3.2009 Imprida Novartis Europharm Limited Wimblehurst Road, Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/06/373/001-036 1.4.2009 27.3.2009 Exforge Novartis Europharm Limited Wimblehurst Road, Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/06/370/001-036 1.4.2009 27.3.2009 Stalevo Orion Corporation Orionintie 1 FIN-02200 Espoo SUOMI EU/1/03/260/024-033 1.4.2009 30.3.2009 Cholestagel Genzyme Europe B.V. Gooimeer 10 NL-1411 DD Naarden NEDERLAND EU/1/03/268/001-004 1.4.2009 31.3.2009 Rapilysin Actavis Group PTC ehf. Reykjavikurvegi 76-78 220 Hafnarfjordur ICELAND EU/1/96/018/001 2.4.2009 31.3.2009 Velcade Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse BELGIË EU/1/04/274/001-002 2.4.2009 31.3.2009 Aprovel Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris FRANCE EU/1/97/046/001-039 2.4.2009 31.3.2009 Karvea Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/97/049/001-039 2.4.2009 31.3.2009 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris FRANCE EU/1/98/086/001-034 2.4.2009

— Withdrawal of a marketing authorization (Article 13 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 17.3.2009 Dynepo Shire Pharmaceutical Contracts Ltd Hampshire International Business Park, Chineham, Basingstoke Hampshire RG24 8EP UNITED KINGDOM EU/1/02/211/001-005 EU/1/02/211/010-012 19.3.2009

— Issuing of a marketing authorization (Article 38 of Regulation (EC) No (2) 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 17.3.2009 BTVPUR Alsap 8 Bluetongue virus Serotype 8 Antigen MERIAL 29 avenue Tony Garnier 69007 LYON FRANCE EU/2/09/094/001-005 Suspension for injection Q104AA02 Q102AA08 19.3.2009

— 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 6.3.2009 Econor Novartis Animal Health Austria GmbH Biochemiestrasse 10 6250 Kundl ÖSTERREICH EU/2/98/010/004-006 EU/2/98/010/017-018 EU/2/98/010/021-024 10.3.2009 12.3.2009 Novem Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein DEUTSCHLAND EU/2/04/042/003-004 16.3.2009 18.3.2009 Aivlosin ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS UNITED KINGDOM EU/2/04/044/001-008 20.3.2009 23.3.2009 Equilis Prequenza Te Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND EU/2/05/057/001-004 25.3.2009 23.3.2009 Equilis Prequenza Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND EU/2/05/056/001-004 25.3.2009 25.3.2009 Quadrisol Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND EU/2/97/005/002-004 EU/2/97/005/006-009 27.3.2009

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.

(2) OJ L 136, 30.4.2004, p. 1.