EN Official Journal of the European Union C 146/6

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2009 to 31 May 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 146/03

— 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 11.5.2009 Nimvastid Rivastigmine KRKA, d.d. Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto SLOVENIJA EU/1/09/525/001-025 EU/1/09/525/026-046 Capsule, hard Orodispersible tablet N06DA03 13.5.2009 15.5.2009 Modigraf Tacrolimus Astellas Pharma Europe B.V. Elisabethhof 19 2353 EW Leiderdorp NEDERLAND EU/1/09/523/001-002 Granules for oral suspension L04AD02 20.5.2009 15.5.2009 Ellaone Ulipristal acetate Laboratoire HRA Pharma 15 rue Béranger 75003 Paris FRANCE EU/1/09/522/001 Tablet Non applicable 20.5.2009 15.5.2009 Qutenza Capsaicin NeurogesX UK Limited 265 Strand London WC2R 1BH UNITED KINGDOM EU/1/09/524/001-002 Cutaneous patch N01BX04 20.5.2009

— 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 5.5.2009 Kinzalkomb Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND EU/1/02/214/001-015 8.5.2009 5.5.2009 Kinzalmono Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND EU/1/98/091/001-014 7.5.2009 6.5.2009 Pritorplus Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND EU/1/02/215/001-021 8.5.2009 6.5.2009 Pritor Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND EU/1/98/089/001-022 8.5.2009 7.5.2009 Viramune Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/97/055/001-004 11.5.2009 7.5.2009 Privigen CSL Behring GmbH Emil von Behring Strasse 76 35041 Marburg DEUTSCHLAND EU/1/08/446/001-004 11.5.2009 7.5.2009 Adenuric Beaufour Ipsen Pharma 24, rue Erlanger 75781 Paris Cedex 16 FRANCE EU/1/08/447/001-004 11.5.2009 11.5.2009 Tamiflu Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/02/222/001 EU/1/02/222/003-004 13.5.2009 15.5.2009 REYATAZ Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/03/267/001-010 20.5.2009 15.5.2009 Oprymea KRKA, d.d. Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto SLOVENIJA EU/1/08/469/001-025 20.5.2009 15.5.2009 Telzir Glaxo Group Ltd. Greenford Road Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/04/282/001-002 20.5.2009 15.5.2009 Tredaptive Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/459/001-014 20.5.2009 15.5.2009 Pelzont Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/460/001-014 20.5.2009 15.5.2009 Trevaclyn Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/458/001-014 20.5.2009 19.5.2009 Adenuric Ipsen Pharma 65 quai Georges Gorse 92100 Boulogne-Billancourt FRANCE Beaufour Ipsen Pharma 24, rue Erlanger 75781 Paris Cedex 16 FRANCE EU/1/08/447/001-004 26.5.2009 20.5.2009 Pramipexole Teva Teva Pharma B.V. Computerweg 10 DR Utrecht 3542 NEDERLAND EU/1/08/490/001-016 26.5.2009 26.5.2009 TORISEL Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/07/424/001 28.5.2009 26.5.2009 Luveris Serono Europe Limited 56, Marsh Wall London E14 9TP UNITED KINGDOM EU/1/00/155/001-006 28.5.2009 26.5.2009 Tysabri Elan Pharma International Ltd. Monksland, Athlone County Westmeath IRELAND EU/1/06/346/001 28.5.2009 26.5.2009 Pritor Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND EU/1/98/089/001-022 28.5.2009 26.5.2009 Zavesca Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL UNITED KINGDOM EU/1/02/238/001 28.5.2009 27.5.2009 TRIZIVIR Glaxo Group Ltd. Greenford Road Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/00/156/002-003 29.5.2009 27.5.2009 Ventavis Bayer Schering Pharma AG Müllerstrasse 170-178 13342 Berlin DEUTSCHLAND EU/1/03/255/001-008 29.5.2009 27.5.2009 Rilutek Aventis Pharma S.A. 20 avenue Raymond Aron 92165 Antony Cedex FRANCE EU/1/96/010/001 29.5.2009 27.5.2009 PritorPlus Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND EU/1/02/215/001-021 29.5.2009 28.5.2009 TESAVEL Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/07/435/001-018 1.6.2009 28.5.2009 ISENTRESS Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/07/436/001-002 1.6.2009 28.5.2009 NovoSeven Novo Nordisk A/S Novo Allé 2880 Bagsværd DANMARK EU/1/96/006/001-006 2.6.2009 28.5.2009 AVANDIA SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS UNITED KINGDOM EU/1/00/137/002-018 1.6.2009 28.5.2009 Soliris Alexion Europe SAS 54-56 Avenue Hoche 75008 Paris FRANCE EU/1/07/393/001 2.6.2009 28.5.2009 Tarceva Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/05/311/001-003 1.6.2009 28.5.2009 Insulin Human Winthrop Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND EU/1/06/368/163-168 2.6.2009 28.5.2009 DepoCyte Pacira Limited West Forest Gate Wellington Road Wokingham Berkshire RG40 2AQ UNITED KINGDOM EU/1/01/187/001 1.6.2009 28.5.2009 Gardasil Sanofi Pasteur MSD SNC 8, rue Jonas Salk 69007 Lyon FRANCE EU/1/06/357/001-021 2.6.2009 29.5.2009 Ebixa H. Lundbeck A/S Ottiliavej 9 2500 Valby DANMARK EU/1/02/219/001-049 3.6.2009 29.5.2009 Micardis Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/98/090/001-020 3.6.2009 29.5.2009 SUTENT Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ UNITED KINGDOM EU/1/06/347/007-008 3.6.2009 29.5.2009 Lyrica Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ UNITED KINGDOM EU/1/04/279/001-043 3.6.2009 29.5.2009 MicardisPlus Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/02/213/001-023 3.6.2009 29.5.2009 Ziagen Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/99/112/001-002 3.6.2009 29.5.2009 CellCept Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/96/005/001-006 3.6.2009 29.5.2009 Xelevia Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/07/382/001-018 3.6.2009 29.5.2009 Viramune Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/97/055/001-004 3.6.2009 29.5.2009 Zostavax Sanofi Pasteur MSD SNC 8, rue Jonas Salk Lyon 69007 FRANCE EU/1/06/341/001-013 3.6.2009 29.5.2009 Replagal Shire Human Genetic Therapies AB Svärdvägen 11D SE-182 33 Danderyd SVERIGE EU/1/01/189/001-006 3.6.2009 29.5.2009 Velcade Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË EU/1/04/274/001-002 3.6.2009 29.5.2009 Aptivus Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/05/315/001 3.6.2009 29.5.2009 Kinzalkomb Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND EU/1/02/214/001-015 3.6.2009 29.5.2009 ORENCIA Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/07/389/001-003 3.6.2009 29.5.2009 Avastin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/04/300/001-002 3.6.2009 29.5.2009 Advate Baxter AG Industriesstrasse 67 1220 Vienna ÖSTERREICH EU/1/03/271/001-006 3.6.2009 29.5.2009 Kinzalmono Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND EU/1/98/091/001-014 3.6.2009 29.5.2009 Enbrel Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/99/126/001-018 3.6.2009 29.5.2009 Insuman Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND EU/1/97/030/028-195 3.6.2009

— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2) ): 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 11.5.2009 Improvac Synthetic peptide analogue of GnRF conjugated to a carrier protein of min. 300 μg per 2 ml dose PFIZER Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/2/09/095/001-003 Solution for injection QI09AX 13.5.2009

— 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 8.5.2009 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 12.5.2009 11.5.2009 Aivlosin ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS UNITED KINGDOM EU/2/04/044/009-010 13.5.2009 19.5.2009 Onsior Novartis Animal Health UK Ltd Frimley Business Park Frimley/Camberley Surrey GU16 7SR UNITED KINGDOM EU/2/08/089/001-020 21.5.2009 25.5.2009 Advocate Bayer Animal Health GmbH 51368 Leverkusen DEUTSCHLAND EU/2/03/039/001-002 EU/2/03/039/013 EU/2/03/039/019-020 27.5.2009 29.5.2009 Previcox Merial 29 Avenue Tony Garnier 69007 Lyon FRANCE EU/2/04/045/001-007 3.6.2009

— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): Rejected

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 7.5.2009 Porcilis Porcoli Intervet International B.V. (NL) Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND EU/2/96/001/003-008 11.5.2009

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 of 30.4.2004, p. 1.