EN Official Journal of the European Union C 121/3

Summary of Community decisions on marketing authorisations in respect of medicinal products

from 1 April 2009 to 30 April 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 121/03

— 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 17.4.2009 Rivastigmine Teva Rivastigmine Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND EU/1/09/513/001-020 Capsule, hard N06DA03 21.4.2009 17.4.2009 CONBRIZA Bazedoxifene Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/09/511/001-004 Film-coated tablet G03XC02 21.4.2009 20.4.2009 Removab Catumaxomab Fresenius Biotech GmbH Am Haag 6-7 82166 Graefelfing DEUTSCHLAND EU/1/09/512/001-002 Concentrate for solution for infusion L01XC09 22.4.2009 21.4.2009 Exalief Eslicarbazepine acetate BIAL - Portela & Ca, SA, A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado PORTUGAL EU/1/09/520/001-020 Tablet N03AF04 23.4.2009 21.4.2009 Zebinix Eslicarbazepine acetate BIAL - Portela & Ca, SA, A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado PORTUGAL EU/1/09/514/001-020 Tablet N03AF04 23.4.2009

— Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004): Rejected

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 27.4.2009 Sovrima Santhera Pharmaceuticals (Deutschland) GmbH Wallbrunnstr. 24 79539 Lörrach DEUTSCHLAND — 29.4.2009

— 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 2.4.2009 Xarelto Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND EU/1/08/472/001-008 6.4.2009 2.4.2009 Altargo Glaxo Group Limited Glaxo Wellcome House Berkely Avenue Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/07/390/001-004 4.4.2009 2.4.2009 Neupro Schwarz Pharma Ltd Shannon Industrial Estate Co. Clare IRELAND EU/1/05/331/001-055 6.4.2009 2.4.2009 Abraxane Abraxis BioScience Limited Hatfield AL10 9NA UNITED KINGDOM EU/1/07/428/001 6.4.2009 2.4.2009 Combivir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/98/058/001-002 4.4.2009 3.4.2009 Optimark Covidien Deutschland GmbH Gewerbepark 1 93333 Neustadt/Donau DEUTSCHLAND EU/1/07/398/001-014 8.4.2008 3.4.2009 Intrinsa Procter & Gamble Pharmaceuticals UK Ltd Rusham Park Technical Centre Whitehall Lane Egham Surrey TW20 9NW UNITED KINGDOM EU/1/06/352/001-003 8.4.2009 3.4.2009 Livensa Procter & Gamble Pharmaceuticals — Germany GmbH Dr Otto-Röhm-Strasse 2-4 64331 Weiterstadt DEUTSCHLAND EU/1/06/351/001-003 8.4.2009 3.4.2009 Riprazo Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/409/001-020 8.4.2009 3.4.2009 Enviage Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/406/001-020 8.4.2009 3.4.2009 Sprimeo Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/407/001-020 8.4.2009 3.4.2009 Tekturna Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/408/001-020 8.4.2009 3.4.2009 Rasilez Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/405/001-020 8.4.2009 3.4.2009 YENTREVE Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/04/280/001-008 8.4.2009 3.4.2009 DULOXETINE BOEHRINGER INGELHEIM Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/08/471/001-012 8.4.2009 7.4.2009 Vectibix Amgen Europe B.V. Minervum 7061 4817 ZK Breda NEDERLAND EU/1/07/423/001-003 9.4.2009 7.4.2009 ADROVANCE Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/06/364/001-009 14.4.2009 7.4.2009 FOSAVANCE Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/05/310/001-009 14.4.2009 7.4.2009 Champix Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ UNITED KINGDOM EU/1/06/360/001-012 9.4.2009 7.4.2009 Volibris Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/08/451/001-004 9.4.2009 7.4.2009 Irbesartan Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/06/375/001-033 9.4.2009 7.4.2009 PritorPlus Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND EU/1/02/215/001-021 9.4.2009 7.4.2009 KOGENATE Bayer Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND EU/1/00/143/001-011 9.4.2009 7.4.2009 Tasigna Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/422/001-004 9.4.2009 7.4.2009 Irbesartan HCT BMS Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/06/369/001-028 9.4.2009 7.4.2009 Helixate NexGen Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND EU/1/00/144/001-004 9.4.2009 7.4.2009 Kinzalkomb Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND EU/1/02/214/001-015 9.4.2009 7.4.2009 Nexavar Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND EU/1/06/342/001 9.4.2009 7.4.2009 Fluticasone furoate GSK Glaxo Group Ltd Greenford Middlesex UB6 ONN UNITED KINGDOM EU/1/08/474/001-003 9.4.2009 7.4.2009 Protopic Astellas Pharma Europe B.V. Elisabethhof 19 2353 EW Leiderdorp NEDERLAND Astellas Pharma GmbH Neumarkter Str. 61 81673 München DEUTSCHLAND EU/1/02/201/001-006 9.4.2009 7.4.2009 MIRCERA Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/07/400/001-021 9.4.2009 7.4.2009 Integrilin Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/99/109/001-002 9.4.2009 7.4.2009 Ziagen Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/99/112/001-002 9.4.2009 7.4.2009 Avamys Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/07/434/001-003 9.4.2009 7.4.2009 MicardisPlus Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/02/213/001-023 9.4.2009 7.4.2009 Thyrogen Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND EU/1/99/122/001-002 9.4.2009 8.4.2009 Irbesartan Winthrop SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174 avenue de France 75013 Paris FRANCE EU/1/06/376/001-033 15.4.2009 8.4.2009 PEGASYS Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/02/221/001-010 15.4.2009 16.4.2009 ReFacto AF Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/99/103/001-004 20.4.2009 16.4.2009 Levemir Novo Nordisk A/S Novo Allé 2880 Bagsvaerd DANMARK EU/1/04/278/001-009 20.4.2009 16.4.2009 Thelin Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ UNITED KINGDOM EU/1/06/353/001-005 21.4.2009 17.4.2009 CUBICIN Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/05/328/001-002 21.4.2009 17.4.2009 Mirapexin Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/97/051/001-006 EU/1/97/051/009-012 21.4.2009 17.4.2009 Irbesartan HCT Winthrop SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174 avenue de France 75013 Paris FRANCE EU/1/06/377/001-028 21.4.2009 17.4.2009 Sifrol Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/97/050/001-006 EU/1/97/050/009-012 21.4.2009 21.4.2009 Trisenox Cephalon Europe 5 Rue Charles Martigny 94700 Maisons Alfort Cedex FRANCE EU/1/02/204/001 23.4.2009 21.4.2009 Kivexa Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/04/298/001-003 23.4.2009 21.4.2009 Prepandrix GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/08/453/001 23.4.2009 21.4.2009 Tasigna Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/422/001-004 23.4.2009 21.4.2009 Pandemrix GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/08/452/001 23.4.2009 21.4.2009 Angiox The Medicines Company UK Ltd 115 L Milton Park Abingdon Oxfordshire OX14 4SA UNITED KINGDOM EU/1/04/289/001-002 23.4.2009 21.4.2009 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 23.4.2009 21.4.2009 ISENTRESS Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/07/436/001-002 23.4.2009 21.4.2009 Renagel Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND EU/1/99/123/005-012 23.4.2009 22.4.2009 Viread Gilead Sciences International Limited Cambridge CB21 6GT UNITED KINGDOM EU/1/01/200/001-002 24.4.2009 22.4.2009 Liprolog Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/01/195/022-027 24.4.2009 22.4.2009 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 24.4.2009 22.4.2009 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 24.4.2009 22.4.2009 BeneFIX Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/97/047/001-007 24.4.2009 22.4.2009 Rebif Serono Europe Limited 56 Marsh Wall London E14 9TP UNITED KINGDOM EU/1/98/063/001-010 24.4.2009 22.4.2009 Cervarix GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/07/419/001-012 24.4.2009 22.4.2009 Enviage Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/406/001-020 24.4.2009 22.4.2009 Riprazo Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/409/001-020 24.4.2009 22.4.2009 Tekturna Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/408/001-020 24.4.2009 22.4.2009 Rasilez Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/405/001-020 24.4.2009 22.4.2009 Sprimeo Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/407/001-020 27.4.2009 23.4.2009 Rebetol Schering Plough Europe Rue de Stalle 73/Stallestraat 73 1180 Bruxelles/Brussel BELGIQUE/BELGIË EU/1/99/107/001-005 28.4.2009 23.4.2009 Corlentor Les Laboratoires Servier 22, rue Garnier 92200 Neuilly-sur-Seine FRANCE EU/1/05/317/001-014 7.5.2009 23.4.2009 Procoralan Les Laboratoires Servier 22, rue Garnier 92200 Neuilly-sur-Seine FRANCE EU/1/05/316/001-014 7.5.2009 23.4.2009 INTELENCE Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË EU/1/08/468/001 28.4.2009 23.4.2009 EVICEL OMRIX biopharmaceuticals S.A./N.V. 200 Chaussée de Waterloo/Waterloosesteenweg 200 1640 Rhode-St-Genèse/1640 Sint-Genesius-Rode BELGIQUE/BELGIË EU/1/08/473/001-003 28.4.2009 24.4.2009 KOGENATE Bayer Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND EU/1/00/143/001-011 28.4.2009 24.4.2009 Helixate NexGen Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND EU/1/00/144/001-004 28.4.2009 27.4.2009 Advagraf Astellas Pharma Europe B.V. Elisabethhof 19 2353 EW Leiderdorp NEDERLAND EU/1/07/387/001-013 29.4.2009 29.4.2009 Glivec Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/01/198/001-013 5.5.2009 29.4.2009 Evoltra Genzyme Europe BV Gooimeer 10 1411 DD Naarden NEDERLAND EU/1/06/334/001-004 5.5.2009 29.4.2009 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 5.5.2009 30.4.2009 NovoRapid Novo Nordisk A/S Novo Allé 2880 Bagsvaerd DANMARK EU/1/99/119/001 EU/1/99/119/003 EU/1/99/119/005-015 5.5.2009 30.4.2009 TachoSil Nycomed Austria GmbH St.-Peter-Strasse 25 4020 Linz ÖSTERREICH EU/1/04/277/001-004 5.5.2009 30.4.2009 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP UNITED KINGDOM EU/1/04/295/001 5.5.2009 30.4.2009 Kentera Nicobrand Limited 189 Castleroe Road Coleraine Northern Ireland BT51 3 RP UNITED KINGDOM EU/1/03/270/001-003 5.5.2009

— Suspension of a marketing authorisation (Article 20 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 17.4.2009 Raptiva Serono Europe Limited 56 Marsh Wall London E14 9TP UNITED KINGDOM EU/1/04/291/001-003 21.4.2009

— 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 16.4.2009 Netvax Clostridium perfringens type A toxoid Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND EU/2/09/093/001-002 Emulsion for injection QI01A08 20.4.2009

— 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 27.4.2009 Equilis StrepE Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND EU/2/04/043/001 29.4.2009

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.