EN Official Journal of the European Union C 228/2

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2007 to 31 August 2007

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )

(2007/C 228/02)

— 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 3.8.2007 INCRELEX Mecasermin Tercica Europe Limited 2 Harbourmaster Place International Financial Services Centre Dublin 1 Ireland EU/1/07/402/001 Solution for injection H01AC03 7.8.2007 22.8.2007 Enviage Aliskiren Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/406/001-020 Film-coated tablet C09XA02 24.8.2007 22.8.2007 Riprazo Aliskiren Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/409/001-020 Film-coated tablet C09XA02 24.8.2007 22.8.2007 Sprimeo Aliskiren Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/407/001-020 Film-coated tablet C09XA02 24.8.2007 22.8.2007 Rasilez Aliskiren Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/405/001-020 Film-coated tablet C09XA02 24.8.2007 22.8.2007 Tekturna Aliskiren Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/408/001-020 Film-coated tablet C09XA02 24.8.2007 22.8.2007 Atriance Nelarabine Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom EU/1/07/403/001 Solution for infusion L01BB07 24.8.2007 23.8.2007 Flebogammadif Human normal immunoglobulin Instituto Grifols S.A. Can Guasch 2 — Parets del Vallès E-08150 Barcelona EU/1/07/404/001-005 Solution for infusion J06BA02 27.8.2007 28.8.2007 Abseamed Epoetin alfa Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 D-58638 Iserlohn EU/1/07/412/001-016 Solution for injection in a pre-filled syringe B03XA01 31.8.2007 28.8.2007 Binocrit Epoetin alfa Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl EU/1/07/410/001-016 Solution for injection in a pre-filled syringe B03XA01 31.8.2007 28.8.2007 Epoetin alfa hexal Epoetin alfa HEXAL Biotech Forschungs GmbH Industriestrasse 25 D-83607 Holzkirchen EU/1/07/411/001-016 Solution for injection in a pre-filled syringe B03XA01 3.9.2007

— 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 1.8.2007 Keppra UCB S.A. Allée de la Recherche, 60 B-1070 Bruxelles Researchdreef, 60 B-1070 Brussel UCB Pharma SA. Allée de la Recherche 60 B-1070 Bruxelles Researchdreef, 60 B-1070 Brussel EU/1/00/146/001-030 3.8.2007 3.8.2007 TachoSil Nycomed Austria GMBH St.-Peter-Straße 25 A-4020 Linz EU/1/04/277/001-004 7.8.2007 7.8.2007 BeneFIX Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/97/047/001-007 9.8.2007 10.8.2007 Norvir Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/96/016/001 EU/1/96/016/003-004 14.8.2007 10.8.2007 Fasturtec Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/00/170/001-002 14.8.2007 10.8.2007 Ceprotin Baxter AG Industriestraße 67 A-1220 Vienna EU/1/01/190/001-002 14.8.2007 10.8.2007 Cellcept Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/005/001-006 14.8.2007 10.8.2007 Rebif Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom EU/1/98/063/001-007 14.8.2007 10.8.2007 Tritanrix HepB GlaxoSmithKline Biologicals S.A. rue de l'Institut, 89 B-1330 Rixensart EU/1/96/014/001-003 14.8.2007 10.8.2007 Cialis Lilly ICOS Limited St Bride's House 10 Salisbury Square London EC4Y 8EH United Kingdom EU/1/02/237/001-008 22.8.2007 20.8.2007 Actos Takeda Global Research and Development Centre (Europe) Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/00/150/001-024 22.8.2007 20.8.2007 Glustin Takeda Global Research and Development Centre (Europe) Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/00/151/001-022 22.8.2007 20.8.2007 Competact Takeda Global Research and Development Centre (Europe) Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/06/354/001-009 22.8.2007 21.8.2007 Forsteo Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/03/247/001-002 23.8.2007 21.8.2007 Nexavar Bayer HealthCare AG D-51368 Leverkusen EU/1/06/342/001 23.8.2007 21.8.2007 Opatanol Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom EU/1/02/217/001-002 23.8.2007 21.8.2007 NeuroBloc Solstice Neurosciences Ltd Fitzwilton House Wilton Place Dublin 2 Ireland EU/1/00/166/001-003 23.8.2007 21.8.2007 Avastin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/04/300/001-002 23.8.2007 21.8.2007 Kiovig Baxter AG Industriestraße 67 A-1220 Vienna EU/1/05/329/001-005 23.8.2007 22.8.2007 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/06/363/001-009 24.8.2007 22.8.2007 Luminity Bristol-Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185 B-1170 Brussel EU/1/06/361/001-002 24.8.2007 22.8.2007 Emtriva Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/03/261/001-003 24.8.2007 22.8.2007 Baraclude Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/06/343/001-005 24.8.2007 23.8.2007 Inovelon Eisai Limited, 3 Shortlands London W6 8EE United Kingdom EU/1/06/378/001-016 28.8.2007 23.8.2007 Stocrin Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/99/111/001-011 28.8.2007 23.8.2007 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/99/110/001-009 28.8.2007 23.8.2007 Orfadin Swedish Orphan International AB Drottninggatan 98 S-111 60 Stockholm EU/1/04/303/001-003 27.8.2007 27.8.2007 Kivexa Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/04/298/001-002 29.8.2007 27.8.2007 Ziagen Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/99/112/001-002 29.8.2007 27.8.2007 Rapamune Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/01/171/001 EU/1/01/171/007-012 29.8.2007 27.8.2007 Prezista Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/06/380/001 29.8.2007 27.8.2007 NovoMix Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/00/142/004-005 EU/1/00/142/009-022 29.8.2007 27.8.2007 Invanz Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/02/216/001-002 29.8.2007 27.8.2007 Tandemact Takeda Global Research and Development Centre (Europe) Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/06/366/001-004 29.8.2007 27.8.2007 Ebixa H. Lundbeck A/S Ottiliavej 9 DK-2500 Valby EU/1/02/219/001-015 29.8.2007 29.8.2007 Enbrel Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/99/126/001-018 31.8.2007 28.8.2007 Cymbalta Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/04/296/001-009 31.8.2007 28.8.2007 Xeristar Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/04/297/001-008 31.8.2007 28.8.2007 YENTREVE Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/04/280/001-008 31.8.2007 28.8.2007 Ariclaim Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/04/283/001-007 31.8.2007 29.8.2007 Stalevo Orion Corporation Orionintie 1 FIN-02200 Espoo EU/1/03/260/001-018 31.8.2007 29.8.2007 Exubera Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/05/327/001-018 31.8.2007 29.8.2007 Vistide Pfizer Enterprises SARL 51, Avenue Kennedy Rond Point du Kirchberg L-1855 Luxembourg EU/1/97/037/001 31.8.2007 29.8.2007 Evoltra Bioenvision Limited Bassett House 5 Southwell Park Road Camberley Surrey GU15 3PU United Kingdom EU/1/06/334/001-004 31.8.2007 29.8.2007 Xelevia Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/07/382/001-018 31.8.2007 29.8.2007 Januvia Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/07/383/001-018 31.8.2007 29.8.2007 Quixidar Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/02/207/001-004 31.8.2007 29.8.2007 Quixidar Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/02/207/001-004 31.8.2007 29.8.2007 Arixtra Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/02/206/001-004 31.8.2007 29.8.2007 Arixtra Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/02/206/001-004 31.8.2007 30.8.2007 Fuzeon Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/03/252/001-003 5.9.2007 30.8.2007 BYETTA Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/06/362/001-004 5.9.2007 30.8.2007 Agenerase Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom EU/1/00/148/001-004 5.9.2007 30.8.2007 Aranesp Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/01/185/001-073 5.9.2007 30.8.2007 NovoRapid Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/99/119/001 EU/1/99/119/003 EU/1/99/119/005-014 5.9.2007 30.8.2007 Nespo Dompé Biotec S.p.A. Via San Martino 12 I-20122 Milano EU/1/01/184/001-073 5.9.2007 30.8.2007 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 5.9.2007 30.8.2007 Zyprexa Velotab Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/99/125/001-016 5.9.2007 30.8.2007 InductOs Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/02/226/001 5.9.2007 30.8.2007 Aldara Laboratoires 3M Santé Boulevard de l'Oise F-95029 Cergy Pontoise Cedex EU/1/98/080/001 5.9.2007 Meda AB Pipers väg 2A S-170 73 Solna 5.9.2007 31.8.2007 Karvea Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/97/049/001-039 6.9.2007 31.8.2007 Aprovel Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France F-75013 Paris EU/1/97/046/001-039 5.9.2007 31.8.2007 CUBICIN Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/05/328/001-002 5.9.2007 31.8.2007 Glustin Takeda Global Research and Development Centre (Europe) Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/00/151/001-024 5.9.2007 31.8.2007 Mimpara Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/04/292/001-012 6.9.2007 31.8.2007 Parareg Dompé Biotec S.p.A. Via San Martino 12 I-20122 Milano EU/1/04/293/001-012 6.9.2007 31.8.2007 Epivir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/96/015/001-005 6.9.2007 31.8.2007 Zimulti Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/06/345/001-011 6.9.2007 31.8.2007 ACOMPLIA Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/06/344/001-011 6.9.2007 31.8.2007 Prevenar Wyeth-Lederle Vaccines S.A. Rue du Bosquet B-15-1348 Louvain-La-Neuve EU/1/00/167/001-007 6.9.2007

— Suspension of a marketing authorization (Article 20 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 6.8.2007 Viracept Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/97/054/001 EU/1/97/054/003-005 8.8.2007

— 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 2.8.2007 Dexdomitor Orion Corporation Orionintie 1 FIN-02200 Espoo EU/2/02/033/001 6.8.2007 13.8.2007 Advocate Bayer HealthCare AG D-51368 Leverkusen EU/2/03/039/001-030 15.8.2007 23.8.2007 PRAC-TIC Novartis Sanidad Animal S.L. Calle de la Marina, 206 E-08013 Barcelona EU/2/06/066/001-012 27.8.2007 27.8.2007 Yarvitan Janssen Animal Health B.V.B.A. Turnhoutseweg, 30 B-2340 Beerse EU/2/06/063/001-003 29.8.2007 Janssen Pharmaceutica N.V. Turnhoutseweg, 30 B-2340 Beerse 29.8.2007

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.