EN Official Journal of the European Union C 22/2

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 November 2009 to 30 November 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 22/02

— 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 4.11.2009 Repaglinide Krka Repaglinide KRKA, d. d. Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto SLOVENIJA EU/1/09/579/001-018 Tablet A10B X02 6.11.2009 4.11.2009 Copalia HCT amlodipine besylate/valsartan/hydrochlorothiazide Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/09/575/001-060 Film-coated tablet C09DX01 6.11.2009 4.11.2009 Dafiro HCT amlodipine besylate/valsartan/hydrochlorothiazide Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/09/574/001-060 Film-coated tablet C09DX01 6.11.2009 26.11.2009 Multaq dronedarone Sanofi-Aventis 174 avenue de France 75013 Paris FRANCE EU/1/09/591/001-004 Film-coated tablet Not applicable 1.12.2009 26.11.2009 Irbesartan/Hydrochlorothiazide Teva hydrochlorothiazide Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND EU/1/09/583/001-072 Film-coated tablet C09D A04 1.12.2009 30.11.2009 Sildenafil Teva Sildenafil Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND EU/1/09/584/001-018 Film-coated tablet G04BE03 2.12.2009 30.11.2009 Nevirapine Teva nevirapine Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND EU/1/09/598/001-004 Tablet J05AG01 2.12.2009 30.11.2009 Hirobriz Breezhaler Indacaterol Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/09/594/001-010 Inhalation powder Not applicable 2.12.2009 30.11.2009 Onbrez Breezhaler Indacaterol Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/09/593/001-010 Inhalation powder Not applicable 2.12.2009 30.11.2009 Oslif Breezhaler Indacaterol Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/09/586/001-010 Inhalation powder Not applicable 2.12.2009 30.11.2009 Zutectra Human Hepatitis B Immunoglobulin Biotest Pharma GmbH Landsteinerstr. 5 63303 Dreieich DEUTSCHLAND EU/1/09/600/001 Solution for injection J06BB04 2.12.2009

— 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 4.11.2009 Intelence Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË EU/1/08/468/001 6.11.2009 4.11.2009 Optisulin Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND EU/1/00/133/001-032 6.11.2009 4.11.2009 Lantus Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND EU/1/00/134/001-037 6.11.2009 4.11.2009 Ketek Aventis Pharma S.A. 20 avenue Raymond Aron 92160 Antony FRANCE EU/1/01/191/001-005 6.11.2009 4.11.2009 Osseor Les Laboratoires Servier 22 rue Garnier 92200 Neuilly-sur-Seine FRANCE EU/1/04/287/001-006 6.11.2009 4.11.2009 Protelos Les Laboratoires Servier 22 rue Garnier 92200 Neuilly-sur-Seine FRANCE EU/1/04/288/001-006 6.11.2009 5.11.2009 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 10.11.2009 5.11.2009 Tyverb Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/07/440/001-002 9.11.2009 5.11.2009 Pre-pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/08/478/001 9.11.2009 5.11.2009 Celsentri Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/07/418/001-010 9.11.2009 5.11.2009 Invega Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË EU/1/07/395/001-095 9.11.2009 5.11.2009 Foscan Biolitec Pharma Ltd United Drug House Magna Drive Dublin 24 IRELAND EU/1/01/197/003-005 9.11.2009 6.11.2009 Fosavance Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/05/310/001-009 10.11.2009 9.11.2009 Januvia Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/07/383/001-018 11.11.2009 11.11.2009 Celvapan Baxter AG Industriestraße 67 1221 Wien ÖSTERREICH EU/1/08/506/001 12.11.2009 11.11.2009 Focetria Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina 1 53100 Siena SI ITALIA EU/1/07/385/001-002 EU/1/07/385/004 12.11.2009 11.11.2009 Pandemrix GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/08/452/001 12.11.2009 11.11.2009 Insuman Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND EU/1/97/030/028-195 13.11.2009 11.11.2009 PegIntron Schering Plough Europe Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË EU/1/00/131/001-050 13.11.2009 11.11.2009 Soliris Alexion Europe S.A.S. 25 boulevard de l'Amiral Bruix 75016 Paris FRANCE EU/1/07/393/001 13.11.2009 11.11.2009 Rebetol Schering Plough Europe Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË EU/1/99/107/001-005 13.11.2009 12.11.2009 Intelence Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË EU/1/08/468/001 17.11.2009 12.11.2009 IntronA Schering Plough Europe Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË EU/1/99/127/001-044 17.11.2009 12.11.2009 ViraferonPeg Schering Plough Europe Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË EU/1/00/132/001-050 17.11.2009 19.11.2009 IntronA Schering Plough Europe Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË EU/1/99/127/031-039 23.11.2009 19.11.2009 Clopidogrel Teva Pharma Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND HCS bvba, H. Kennisstraat 53 2650 Edegem BELGIË EU/1/09/561/001-009 23.11.2009 20.11.2009 Circadin RAD Neurim Pharmaceuticals EEC Limited One Forbury Square The Forbury, Reading Berkshire RG1 3EB UNITED KINGDOM EU/1/07/392/001-002 18.12.2009 20.11.2009 Bondronat Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/96/012/004 EU/1/96/012/009-013 24.11.2009 20.11.2009 Ebixa H. Lundbeck A/S Ottiliavej 9 2500 Valby DANMARK EU/1/02/219/001-003 EU/1/02/219/005-049 24.11.2009 20.11.2009 Mycamine Astellas Pharma Europe B.V. Elisabethhof 19 2353 EW Leiderdorp NEDERLAND EU/1/08/448/001-002 24.11.2009 20.11.2009 NeoRecormon Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/97/031/019-046 24.11.2009 20.11.2009 MabCampath Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND EU/1/01/193/001-002 24.11.2009 20.11.2009 Somavert Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/02/240/001-004 24.11.2009 20.11.2009 Reyataz Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/03/267/001-010 24.11.2009 20.11.2009 Xeristar Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/04/297/001-008 24.11.2009 20.11.2009 Regranex Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË EU/1/99/101/001 24.11.2009 20.11.2009 Ziagen Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/99/112/001-002 24.11.2009 20.11.2009 Cymbalta Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/04/296/001-009 24.11.2009 20.11.2009 Angiox The Medicines Company UK Ltd 115 L Milton Park Abingdon Oxfordshire OX14 4SA UNITED KINGDOM EU/1/04/289/001-002 24.11.2009 20.11.2009 Agenerase Glaxo Group Limited Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/00/148/001-004 24.11.2009 20.11.2009 RoActemra Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/08/492/001-006 24.11.2009 23.11.2009 Nexavar Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND EU/1/06/342/001 25.11.2009 23.11.2009 Noxafil SP Europe Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË EU/1/05/320/001 25.11.2009 23.11.2009 Pritor Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND EU/1/98/089/001-022 25.11.2009 23.11.2009 Aptivus Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/05/315/001-002 26.11.2009 23.11.2009 Exjade Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/06/356/001-009 25.11.2009 23.11.2009 Cervarix GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/07/419/001-012 25.11.2009 23.11.2009 Trizivir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/00/156/002-003 25.11.2009 23.11.2009 Telzir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/04/282/001-002 25.11.2009 23.11.2009 Azilect Teva Pharma GmbH Kandelstrasse 10 79199 Kirchzarten DEUTSCHLAND EU/1/04/304/001-007 25.11.2009 23.11.2009 Invega Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË EU/1/07/395/001-095 25.11.2009 23.11.2009 Puregon Organon N.V. Kloosterstraat 6 Postbus 20 5340 BH Oss NEDERLAND EU/1/96/008/001-041 25.11.2009 23.11.2009 Kinzalmono Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND EU/1/98/091/001-014 25.11.2009 23.11.2009 Micardis Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/98/090/001-020 26.11.2009 23.11.2009 Kaletra Abbott Laboratories Ltd Queenborough Kent ME11 5EL UNITED KINGDOM EU/1/01/172/001-007 25.11.2009 24.11.2009 Synagis Abbott Laboratories Ltd Queenborough Kent ME11 5EL UNITED KINGDOM EU/1/99/117/001-002 26.11.2009 24.11.2009 alli Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/07/401/007-010 26.11.2009 25.11.2009 Kivexa Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/04/298/001-003 27.11.2009 26.11.2009 Enbrel Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/99/126/001-021 1.12.2009 26.11.2009 Enbrel Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/99/126/001-021 1.12.2009 26.11.2009 Diacomit Biocodex 7 avenue Gallieni 94250 Gentilly FRANCE EU/1/06/367/001-012 1.12.2009 26.11.2009 Intelence Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË EU/1/08/468/001 1.12.2009 26.11.2009 Abseamed Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 58638 Iserlohn DEUTSCHLAND EU/1/07/412/021-026 1.12.2009 27.11.2009 Pandemrix GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/08/452/001 30.11.2009 27.11.2009 Focetria Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina 1 53100 Siena SI ITALIA EU/1/07/385/001-002 EU/1/07/385/004 30.11.2009 30.11.2009 Velcade Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË EU/1/04/274/001-002 2.12.2009 30.11.2009 Champix Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/06/360/001-013 2.12.2009 30.11.2009 Adcirca Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/08/476/001-006 2.12.2009 30.11.2009 Docetaxel Winthrop Aventis Pharma S.A. 20 avenue Raymond Aron 92165 Antony Cedex FRANCE EU/1/07/384/003-004 2.12.2009 30.11.2009 Taxotere Aventis Pharma S.A. 20 avenue Raymond Aron 92165 Antony Cedex FRANCE EU/1/95/002/003-004 2.12.2009

— 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 11.11.2009 Irbesartan BMS Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/06/375/001-033 13.11.2009 11.11.2009 Irbesartan HCT BMS Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/06/369/001-028 13.11.2009 12.11.2009 Clopidogrel BMS Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/08/464/001-019 17.11.2009 26.11.2009 Paxene Norton Healthcare Limited Albert Basin Royal Docks London E16 2QJ UNITED KINGDOM EU/1/99/113/001-004 10.12.2009

— Issuing of a marketing 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 4.11.2009 Zolvix Monepantel Novartis Healthcare A/S Lyngbyvej 172 2100 Copenhagen DANMARK EU/2/09/101/001-010 Oral solution QP52AX09 6.11.2009

— 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 18.11.2009 Dexdomitor Orion Corporation Orionintie 1 FI-02200 Espoo SUOMI/FINLAND EU/2/02/033/001-002 20.11.2009 19.11.2009 Improvac Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/2/09/095/001-003 23.11.2009 20.11.2009 Metacam Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein DEUTSCHLAND EU/2/97/004/026 EU/2/97/004/033-034 24.11.2009 23.11.2009 Halocur Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND EU/2/99/013/001-002 25.11.2009

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.