EN Official Journal of the European Union C 178/15

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 June 2009 to 30 June 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 178/12

— Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 10.6.2009 Renvela Sevelamer (carbonate) Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND EU/1/09/521/001-003 EU/1/09/521/004-007 Film-coated tablet Powder for oral suspension V03AE02 12.6.2009 12.6.2009 PANTOLOC Control Pantoprazole Nycomed GmbH Byk-Gulden-Str. 2 78467 Konstanz DEUTSCHLAND EU/1/09/519/001-004 Gastro-resistant tablet A02BC02 16.6.2009 12.6.2009 PANTOZOL Control Pantoprazole Nycomed GmbH Byk-Gulden-Str. 2 78467 Konstanz DEUTSCHLAND EU/1/09/517/001-004 Gastro-resistant tablet A02BC02 16.6.2009 12.6.2009 PANTECTA Control Pantoprazole Nycomed GmbH Byk-Gulden-Str. 2 78467 Konstanz DEUTSCHLAND EU/1/09/518/001-004 Gastro-resistant tablet A02BC02 16.6.2009 12.6.2009 CONTROLOC Control Pantoprazole Nycomed GmbH Byk-Gulden-Str. 2 78467 Konstanz DEUTSCHLAND EU/1/09/515/001-004 Gastro-resistant tablet A02BC02 16.6.2009 12.6.2009 SOMAC Control Pantoprazole Nycomed GmbH Byk-Gulden-Str. 2 78467 Konstanz DEUTSCHLAND EU/1/09/516/001-004 Gastro-resistant tablet A02BC02 16.6.2009 24.6.2009 IRESSA Gefitinib AstraZeneca AB SE-151 85 Sodertalje SVERIGE EU/1/09/526/001 Film-coated tablet L01XE02 26.6.2009 29.6.2009 Repaglinide Teva Repaglinide Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND EU/1/09/530/001-015 Tablet A10BX02 1.7.2009 30.6.2009 Victoza Liraglutide Novo Nordisk A/S Novo Allé 2880 Bagsvaerd DANMARK EU/1/09/529/001-005 Solution for injection in pre-filled pen A10BX07 2.7.2009

— Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 2.6.2009 Avamys Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/07/434/001-003 5.6.2009 2.6.2009 Alisade Glaxo Group Ltd Greenford Middlesex UB6 ONN UNITED KINGDOM EU/1/08/474/001-003 5.6.2009 2.6.2009 Ketek Aventis Pharma S.A. 20 avenue Raymond Aron 92160 Antony FRANCE EU/1/01/191/001-005 5.6.2009 2.6.2009 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 5.6.2009 2.6.2009 Velmetia Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/456/001-016 5.6.2009 2.6.2009 Ferriprox Apotex Europe B.V. Darwingweg 20 2333 CR Leiden NEDERLAND EU/1/99/108/001-003 4.6.2009 2.6.2009 Januvia Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/07/383/001-018 5.6.2009 2.6.2009 Janumet Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/455/001-016 5.6.2009 2.6.2009 Silgard Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/06/358/001-021 4.6.2009 2.6.2009 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 5.6.2009 2.6.2009 Efficib Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/457/001-016 5.6.2009 4.6.2009 Avandamet SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS UNITED KINGDOM EU/1/03/258/001-022 8.6.2009 4.6.2009 Ovitrelle Serono Europe Limited 56 Marsh Wall London E14 9TP UNITED KINGDOM EU/1/00/165/001-007 8.6.2009 8.6.2009 Tasigna Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/422/001-004 10.6.2009 8.6.2009 Ziagen Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/99/112/001-002 10.6.2009 8.6.2009 Pergoveris Serono Europe Limited 56 Marsh Wall London E14 9TP UNITED KINGDOM EU/1/07/396/001-003 10.6.2009 8.6.2009 Baraclude Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/06/343/001-007 10.6.2009 8.6.2009 REYATAZ Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/03/267/001-010 10.6.2009 8.6.2009 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 10.6.2009 8.6.2009 Kivexa Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/04/298/001-003 10.6.2009 9.6.2009 GONAL-f Serono Europe Limited 56 Marsh Wall London E14 9TP UNITED KINGDOM EU/1/95/001/001 EU/1/95/001/003-005 EU/1/95/001/009 EU/1/95/001/012 EU/1/95/001/021-022 EU/1/95/001/025-028 EU/1/95/001/031-035 11.6.2009 17.6.2009 Erbitux Merck KGaA Frankfurter Straße 250 64271 Darmstadt DEUTSCHLAND EU/1/04/281/001-005 19.6.2009 17.6.2009 Lucentis Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/06/374/001 19.6.2009 18.6.2009 Vivanza Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer AG 51368 Leverkusen DEUTSCHLAND EU/1/03/249/001-012 22.6.2009 18.6.2009 Vasovist TMC Pharma Services Ltd Eversley Hampshire RG27 0NT UNITED KINGDOM Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND EU/1/05/313/001-009 22.6.2009 18.6.2009 Angiox The Medicines Company UK Ltd 115 L Milton Park Abingdon Oxfordshire OX14 4SA UNITED KINGDOM EU/1/04/289/001-002 22.6.2009 18.6.2009 Emtriva Gilead Sciences International Limited Cambridge CB21 6GT UNITED KINGDOM EU/1/03/261/001-002 22.6.2009 22.6.2009 Aclasta Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/05/308/001-002 24.6.2009 22.6.2009 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 24.6.2009 22.6.2009 Levitra Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer AG 51368 Leverkusen DEUTSCHLAND EU/1/03/248/001-012 25.6.2009 23.6.2009 Ebixa H. Lundbeck A/S Ottiliavej 9 2500 Valby DANMARK EU/1/02/219/001-049 25.6.2009 23.6.2009 Prezista Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË EU/1/06/380/004-005 25.6.2009 23.6.2009 Prezista Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË EU/1/06/380/001-002 25.6.2009 23.6.2009 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 25.6.2009 23.6.2009 Aptivus Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/05/315/002 25.6.2009 23.6.2009 Aptivus Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/05/315/001 25.6.2009 24.6.2009 Ariclaim Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/04/283/008-012 26.6.2009 24.6.2009 YENTREVE Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/04/280/001-008 26.6.2009 24.6.2009 Xeristar Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/04/297/001-008 29.6.2009 24.6.2009 Neupro Schwarz Pharma Ltd Shannon Industrial Estate Co. Clare IRELAND EU/1/05/331/001-055 26.6.2009 24.6.2009 Cymbalta Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/04/296/001-009 26.6.2009 24.6.2009 Axura Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104 60318 Frankfurt/Main DEUTSCHLAND EU/1/02/218/001-029 26.6.2009 29.6.2009 RotaTeq Sanofi Pasteur MSD, SNC 8 rue Jonas Salk 69007 Lyon FRANCE EU/1/06/348/001-002 2.7.2009 29.6.2009 Yttriga Nuclitec GmbH Gieselweg 1 38110 Braunschweig DEUTSCHLAND EU/1/05/322/001 1.7.2009 29.6.2009 Kepivance Biovitrum AB (publ) SE-112 76 Stockholm SVERIGE EU/1/05/314/001 2.7.2009 29.6.2009 Effentora Cephalon Europe 5 rue Charles Martigny 94700 Maisons-Alfort FRANCE EU/1/08/441/001-010 1.7.2009 30.6.2009 Cerezyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND EU/1/97/053/001-005 2.7.2009 30.6.2009 Hepsera Gilead Sciences International Limited Cambridge CB21 6GT UNITED KINGDOM EU/1/03/251/001-002 2.7.2009 30.6.2009 Kineret Biovitrum AB (publ) SE-112 76 Stockholm SVERIGE EU/1/02/203/001-004 2.7.2009 30.6.2009 Ariclaim Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/04/283/008-012 2.7.2009 30.6.2009 BeneFIX Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/97/047/001-007 2.7.2009

— Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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 9.6.2009 Raptiva Serono Europe Limited 56 Marsh Wall London E14 9TP UNITED KINGDOM EU/1/04/291/001-003 11.6.2009

— Issuing of a marketing authorisation (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 authorisation Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 17.6.2009 Leucogen Virbac 1ère avenue 2065 m L.I.D. 06516 Carros Cedex FRANCE EU/2/09/096/001-002 Suspension for injection QI06AA01 19.6.2009 25.6.2009 Leucofeligen FeLV/RCP Virbac 1ère avenue 2065 m L.I.D. 06516 Carros Cedex FRANCE EU/2/09/097/001-002 Lyophilisate and solvent for suspension for injection QI06AH07 29.6.2009

— Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 4.6.2009 Rheumocam Chanelle Pharmaceuticals Manufacturing Limited Loughrea Co. Galway IRELAND EU/2/07/078/001-004 8.6.2009 8.6.2009 Circovac Merial 29 avenue Tony Garnier 69007 Lyon FRANCE EU/2/07/075/001-004 10.6.2009 22.6.2009 ProMeris Fort Dodge Animal Health Holland C.J. van Houtenlaan 36 1381 CP Weesp NEDERLAND EU/2/06/064/001-004 25.6.2009 30.6.2009 Posatex Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND S-P Veterinary Shire Park Welwyn Garden City Hertfordshire AL7 1TW UNITED KINGDOM EU/2/08/081/001-003 2.7.2009

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.