EN Official Journal of the European Union C 19/4

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

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

(2008/C 19/04)

— 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 11.12.2007 NEVANAC Nepafenac Alcon Laboratories (UK) Ltd Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom EU/1/07/433/001 Eye drops, suspension S01BC10 13.12.2007 11.12.2007 Pioglitazone/metformin hydrochloride Takeda Pioglitazone/metformin hydrochloride Takeda Global Research and Development Centre (Europe) Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/07/421/001-009 Film-coated tablet A10BD05 13.12.2007 12.12.2007 Olanzapine Teva Olanzapine Teva Pharma B.V. Computerweg 10 3542 DR Utrecht Nederland EU/1/07/427/001-022 Film-coated tablet N05AH03 14.12.2008 EU/1/07/427023-037 Orodispersible tablets 13.12.2007 Atripla Efavirenz/emtricitabine/tenofovir disoproxil fumarate Bristol-Myers Squibb Gilead Sciences And Merck Sharp & Dohme Limited Unit 13 Stillorgan Industrial Park Blackrock, Co.Dublin Ireland EU/1/07/430/001 Film-coated tablet J05AR06 18.12.2008 18.12.2007 Retacrit Epoetin zeta HOSPIRA Enterprises B.V. Taurusavenue 19-21b 2132 LS Hoofddorp Nederland EU/1/07/431/001-019 Solution for injection B03XA01 20.12.2007 18.12.2007 Silapo Epoetin zeta STADA Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vilbel EU/1/07/432/001-019 Solution for injection B03XA01 20.12.2007 20.12.2007 ISENTRESS Raltegravir Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/07/436/001-002 Film-coated tablets J05AX08 2.1.2008

— 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 11.12.2007 RotaTeq Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/348/001-002 13.12.2007 11.12.2007 TARGRETIN Eisai Limited 3, Shortlands London W6 8EE United Kingdom EU/1/01/178/001 13.12.2007 11.12.2007 Quintanrix GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/04/301/001-005 13.12.2007 11.12.2007 Tandemact Takeda Global Research and Development Centre (Europe) Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/06/366/005-016 13.12.2007 11.12.2007 Procomvax Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/99/104/001 13.12.2007 11.12.2007 Prevenar Wyeth-Lederle Vaccines S.A. Rue du Bosquet 15 B-1348 Louvain-La-Neuve EU/1/00/167/001-007 13.12.2007 12.12.2007 Quadramet CIS bio international Boite Postale 32 F-91192 Gif-sur-Yvette EU/1/97/057/001 14.12.2007 12.12.2007 Sonata Meda AB Pipers väg 2A S-170 09 Solna EU/1/99/102/001-008 17.12.2007 Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom 14.12.2007 14.12.2007 Avastin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/04/300/001-002 18.12.2007 14.12.2007 Ariclaim Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/04/283/008-012 18.12.2007 14.12.2007 Caelyx Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel EU/1/96/011/001-004 18.12.2007 14.12.2007 Diacomit Biocodex 7, avenue Gallieni F-94250 Gentilly EU/1/06/367/001-012 18.12.2007 14.12.2007 RotaTeq Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/348/001-002 18.12.2007 14.12.2007 Rebif Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom EU/1/98/063/001-007 18.12.2007 14.12.2007 Velcade Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/04/274/001 18.12.2007 18.12.2007 Tracleer Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom EU/1/02/220/001-005 20.12.2007 18.12.2007 Xelevia Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/07/382/001-018 20.12.2007 18.12.2007 Infanrix Penta GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/00/153/001-010 20.12.2007 18.12.2007 Lyrica Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/04/279/001-043 21.12.2007 18.12.2007 Prezista Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/06/380/001 20.12.2007 18.12.2007 Betaferon Bayer Schering Pharma AG Müllerstraße 170-178 D-13342 Berlin EU/1/95/003/003-006 20.12.2007 18.12.2007 Helixate NexGen Bayer HealthCare AG D-51368 Leverkusen EU/1/00/144/004 20.12.2007 18.12.2007 KOGENATE Bayer Bayer HealthCare AG D-51368 Leverkusen EU/1/00/143/010-011 20.12.2007 18.12.2007 Zonegran Eisai Limited 3, Shortlands London W6 8EE United Kingdom EU/1/04/307/001-013 20.12.2007 18.12.2007 NovoMix Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/00/142/004-005 EU/1/00/142/009-010 20.12.2007 18.12.2007 Insuman Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/97/030/028-109 EU/1/97/030/085-139 20.12.2007 18.12.2007 Truvada Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/04/305/001 20.12.2007 19.12.2007 CUBICIN Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/05/328/001-002 21.12.2007 19.12.2007 Humira Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/03/256/001-010 21.12.2007 19.12.2007 Tygacil Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/06/336/001 21.12.2007 19.12.2007 MabCampath Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/01/193/001-002 21.12.2007 19.12.2007 Lucentis Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/374/001 21.12.2007 19.12.2007 REYATAZ Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/03/267/001-007 21.12.2007 19.12.2007 Januvia Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/07/383/001-018 21.12.2007 19.12.2007 Aptivus Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/05/315/001 21.12.2007 20.12.2007 Infanrix Hexa GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/00/152/001-018 24.12.2007 20.12.2007 Aldurazyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/03/253/001-003 24.12.2007 20.12.2007 Insulin Human Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/06/368/001-087 27.12.2007 21.12.2007 Remicade Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland EU/1/99/116/001-003 27.12.2007 21.12.2007 Keppra UCB Pharma SA. Allée de la Recherche 60 B-1070 Bruxelles Researchdreef, 60 B-1070 Brussel EU/1/00/146/001-030 26.12.2007 21.12.2007 Mimpara Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/04/292/001-012 27.12.2007 21.12.2007 Macugen Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/05/325/002 2.1.2008 21.12.2007 Somavert Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/02/240/001-004 27.12.2007 21.12.2007 Parareg Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano EU/1/04/293/001-012 2.1.2008 21.12.2007 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 2.1.2008 21.12.2007 HBVAXPRO Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/01/183/001 EU/1/01/183/004-005 EU/1/01/183/007-008 EU/1/01/183/011 EU/1/01/183/013 EU/1/01/183/015 EU/1/01/183/018-029 26.12.2007

— Withdrawal of a marketing authorization (Article 13 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 18.12.2007 Levviax Aventis Pharma S.A 20, avenue Raymond Aron F-92165 Antony Cedex EU/1/01/192/001-005 20.12.2007

— 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 14.12.2007 Suprelorin Cyton Biosciences Ltd Hyland Mews 21 High Street Clifton Bristol BS8 2YF United Kingdom VIRBAC S.A. 1ère Avenue 2065 m L.I.D F-06516 Carros EU/2/07/072/001-002 18.12.2007 19.12.2007 Aivlosin ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom EU/2/04/044/001-006 21.12.2007

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.