EN Official Journal of the European Union C 39/7

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2007 to 31 January 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 39/09)

— Issuing of a marketing authorization (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 authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 4.1.2007 ADROVANCE Alendronate sodium/Colecalciferol Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/06/364/001-005 Tablet (Non applicable) 9.1.2007 4.1.2007 Diacomit Stiripentol Biocodex 7, avenue Gallieni F-94250 Gentilly EU/1/06/367/001-006 Capsule N03AX17 9.1.2007 EU/1/06/367/007-012 Powder for oral suspension 8.1.2007 Elaprase Idursulfase Shire Human Genetic Therapies AB Rinkebyvägen 11B SE-182 36 Danderyd EU/1/06/365/001-003 Concentrate for solution for infusion A16AB09 10.1.2007 8.1.2007 Tandemact Pioglitazone/Glimepiride 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 Tablet (Non applicable) 10.1.2007 16.1.2007 Inovelon rufinamide Eisai Limited 3, Shortlands London W6 8EE United Kingdom EU/1/06/378/001-016 Film-coated tablet N03AF03 18.1.2007 16.1.2007 Dafiro amlodipine/valsartan Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/371/001-024 Film-coated tablet C09DB01 18.1.2007 16.1.2007 Copalia amlodipine/valsartan Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/372/001-024 Film-coated tablet C09DB01 18.1.2007 17.1.2007 Exforge amlodipine/valsartan Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/370/001-024 Film-coated tablet C09DB01 19.1.2007 17.1.2007 Imprida amlodipine/valsartan Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/373/001-024 Film-coated tablet C09DB01 19.1.2007 17.1.2007 Insulin Human Winthrop insulin human Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/06/368/001-002 EU/1/06/368/011-015 EU/1/06/368/056-057 Solution for injection A10AB01 2.2.2007 EU/1/06/368/003-010 EU/1/06/368/020-024 EU/1/06/368/029-033 EU/1/06/368/038-042 EU/1/06/368/047-051 Suspension for injection EU/1/06/368/016-019 EU/1/06/368/025-028 EU/1/06/368/034-037 EU/1/06/368/043-046 EU/1/06/368/052-055 OptiSet, solution for injection 19.1.2007 Irbesartan BMS irbesartan Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/06/375/001-015 Tablet C09CA04 23.1.2007 EU/1/06/375/016-033 Film-coated tablets 19.1.2007 Irbesartan Hydrochlorothiazide BMS irbesartan/hydrochlorothiazide Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/06/369/001-010 Tablet C09DA04 23.1.2007 EU/1/06/369/011-028 Film-coated tablets 19.1.2007 Irbesartan Winthrop Irbesartan SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174, avenue de France F-75013 Paris EU/1/06/376/001-015 Tablet C09CA04 23.1.2007 EU/1/06/376/016-033 Film-coated tablets 19.1.2007 Irbesartan Hydrochlorothiazide Winthrop irbesartan/hydrochlorothiazide SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174, avenue de France F-75013 Paris EU/1/06/377/001-010 Tablet C09DA04 23.1.2007 EU/1/06/377/011-028 Film-coated tablets 22.1.2007 Lucentis ranibizumab Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/374/001 Solution for injection S01LA04 24.1.2007

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 16.1.2007 Thymanax Les Laboratoires Servier 22, rue Garnier F-92200 Neuilly-sur-Seine — 18.1.2007 16.1.2007 Valdoxan Les Laboratoires Servier 22, rue Garnier F-92200 Neuilly-sur-Seine — 18.1.2007

— Modification of a marketing authorization (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 authorization Number of the entry in the Community Register Date of notification 3.1.2007 MicardisPlus Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein EU/1/02/213/001-016 9.1.2007 3.1.2007 Neulasta Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/02/227/001-003 9.1.2007 3.1.2007 Neupopeg Dompé Biotec S.p.A. Via San Martino 12 I-20122 Milano EU/1/02/228/001-003 9.1.2007 3.1.2007 Invirase Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/026/001-002 9.1.2007 3.1.2007 Ceprotin Baxter AG Industriesstrasse 67 A-1220 Vienna EU/1/01/190/001-002 9.1.2007 3.1.2007 Ambirix GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/02/224/ 001-005 9.1.2007 3.1.2007 Velcade Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse EU/1/04/274/001 9.1.2007 3.1.2007 Zostavax Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/341/001-013 9.1.2007 3.1.2007 Nexavar Bayer HealthCare AG D-51368 Leverkusen EU/1/06/342/001 9.1.2007 3.1.2007 Telzir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 9.1.2007 4.1.2007 Twinrix Paediatric GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/97/029/001-010 9.1.2007 4.1.2007 NovoSeven Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/96/006/001-003 9.1.2007 4.1.2007 PEGASYS Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/221/001-010 9.1.2007 4.1.2007 Kinzalmono Bayer HealthCare AG D-51368 Leverkusen EU/1/98/091/001-014 9.1.2007 4.1.2007 Twinrix Adult GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/96/020/001-009 9.1.2007 4.1.2007 NeoRecormon Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/97/031/001-003 EU/1/97/031/019-046 9.1.2007 4.1.2007 Micardis Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein EU/1/98/090/001-020 9.1.2007 4.1.2007 Rebetol Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat 73 B-1180 Brussel EU/1/99/107/001-005 9.1.2007 4.1.2007 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 9.1.2007 4.1.2007 Remicade Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland EU/1/99/116/001-003 9.1.2007 4.1.2007 Ketek Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 Antony EU/1/01/191/001-005 9.1.2007 4.1.2007 Levviax Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 Antony EU/1/01/192/001-005 9.1.2007 4.1.2007 Temodal Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat 73 B-1180 Brussel EU/1/98/096/001-008 9.1.2007 4.1.2007 Keppra UCB S.A. Allée de la recherche, 60 B-1070 Bruxelles Researchdreef 60 B-1070 Brussel EU/1/00/146/001-030 10.1.2007 4.1.2007 Kinzalkomb Bayer HealthCare AG D-51368 Leverkusen EU/1/02/214/001-010 9.1.2007 8.1.2007 PritorPlus Bayer HealthCare AG D-51368 Leverkusen EU/1/02/215/001-014 10.1.2007 8.1.2007 Pritor Bayer HealthCare AG D-51368 Leverkusen EU/1/98/089/001-022 10.1.2007 8.1.2007 DepoCyte SkyePharma PLC 105 Piccadilly London W1J 7NJ United Kindgom EU/1/01/187/001 10.1.2007 8.1.2007 Agenerase Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/00/148/001-004 10.1.2007 8.1.2007 IntronA Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat 73 B-1180 Brussel EU/1/99/127/001-044 10.1.2007 8.1.2007 Viread Gilead Sciences International Limited Cambridge CB1 6GT United Kingdom EU/1/01/200/001 10.1.2007 9.1.2007 Puregon Organon N.V. P.O. Box 20 5340 BH Oss Nederland EU/1/96/008/001-041 11.1.2007 9.1.2007 Neupro Schwarz Pharma Ltd Shannon, Industrial Estate Co.Clare Ireland EU/1/05/331/001-037 11.1.2007 9.1.2007 Viraferon Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat 73 B-1180 Brussel EU/1/99/128/001-037 11.1.2007 9.1.2007 Thyrogen Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/99/122/001-002 11.1.2007 11.1.2007 Karvezide Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/98/085/001-028 15.1.2007 11.1.2007 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris EU/1/98/086/001-028 15.1.2007 11.1.2007 Sutent Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/06/347/001-003 15.1.2007 11.1.2007 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 15.1.2007 11.1.2007 Invirase Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/026/001-002 15.1.2007 11.1.2007 Karvezide Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/98/085/001-028 15.1.2007 12.1.2007 MabThera Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/98/067/001-002 16.1.2007 12.1.2007 Truvada Gilead Sciences International Limited Granta Park Abington Cambridge CB1 6GT United Kingdom EU/1/04/305/001 16.1.2007 12.1.2007 Emtriva Gilead Sciences International Limited Granta Park Abington Cambridge CB1 6GT United Kingdom EU/1/03/261/001-003 16.1.2007 12.1.2007 Norvir Abbott laboratories Ltd Queenborough Kent ME11 5EL United-Kingdom EU/1/96/016/001 EU/1/96/016/003-004 16.1.2007 15.1.2007 Stocrin Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/99/111/001-011 18.1.2007 15.1.2007 Viramune Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein EU/1/97/055/001-003 18.1.2007 15.1.2007 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/99/110/001-009 18.1.2007 15.1.2007 Viread Gilead Sciences International Limited Cambridge CB1 6GT United Kingdom EU/1/01/200/001 18.1.2007 16.1.2007 Insuman Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/97/030/028-084 2.2.2007 16.1.2007 Kaletra Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/01/172/001-005 18.1.2007 17.1.2007 REYATAZ Bristol-Myers Squibb Pharma EEIG 141-149 Staines Road Hounslow TW3 3JA United Kingdom EU/1/03/267/001-007 19.1.2007 17.1.2007 Revatio Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom. EU/1/05/318/001 19.1.2007 17.1.2007 SUTENT Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/06/347/001-003 19.1.2007 17.1.2007 Kivexa Glaxo Group Ltd Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom EU/1/04/298/001-002 19.1.2007 17.1.2007 Lyrica Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/04/279/001-035 19.1.2007 17.1.2007 Advate Baxter AG Industriestraße 67 A-1221 Wien EU/1/03/271/001-004 19.1.2007 17.1.2007 Ziagen Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/99/112/001-002 19.1.2007 18.1.2007 Telzir Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 22.1.2007 18.1.2007 Avaglim SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/06/349/001-008 22.1.2007 18.1.2007 Enbrel Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/99/126/001-018 22.1.2007 19.1.2007 Zerit Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/96/009/001-009 23.1.2007 24.1.2007 Stalevo Orion Corporation Orionintie 1 FIN-02200 Espoo EU/1/03/260/001-015 26.1.2007 24.1.2007 Paxene Norton Healthcare Limited Albert Basin Royal Docks London E16 2QJ United Kingdom EU/1/99/113/001-004 26.1.2007 24.1.2007 Comtess Orion Corporation Orionintie 1 FIN-02200 Espoo EU/1/98/082/001-003 EU/1/98/082/005 26.1.2007 24.1.2007 Fuzeon Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/03/252/001-003 26.1.2007 24.1.2007 TRIZIVIR Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/00/156/002-003 26.1.2007 24.1.2007 Agenerase Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/00/148/001-004 26.1.2007 24.1.2007 Fabrazyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/01/188/001-006 26.1.2007 24.1.2007 Tarceva Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/05/311/001-003 26.1.2007 24.1.2007 Avandamet SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/03/258/001-022 26.1.2007 24.1.2007 Aptivus Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein EU/1/05/315/001 26.1.2007 24.1.2007 Nexavar Bayer HealthCare AG D-51368 Leverkusen EU/1/06/342/001 26.1.2007 24.1.2007 Crixivan Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United-Kingdom EU/1/96/024/001-005 EU/1/96/024/007-008 EU/1/96/024/010 26.1.2007 25.1.2007 Evra Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse EU/1/02/223/001-003 29.1.2007 25.1.2007 Epivir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/96/015/001-005 29.1.2007 26.1.2007 Alimta Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/04/290/001 30.1.2007 26.1.2007 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 30.1.2007 26.1.2007 Combivir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/98/058/001-002 30.1.2007 26.1.2007 Helixate NexGen Bayer HealthCare AG D-51368 Leverkusen EU/1/00/144/001-003 30.1.2007 26.1.2007 TARGRETIN Ligand Pharmaceuticals UK Ltd Innovis House 108 High Street Crawley West Sussex RH10 1BB United Kingdom EU/1/01/178/001 30.1.2007 29.1.2007 KOGENATE Bayer Bayer HealthCare AG D-51368 Leverkusen EU/1/00/143/001-009 31.1.2007 31.1.2007 Avonex Biogen Idec Ltd 5 Roxborough Way Foundation Park Maidenhead Berkshire SL6 3UD United Kindgom EU/1/97/033/001-003 2.2.2007

— Issuing of a marketing authorization (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 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 9.1.2007 Cortavance Hydrocortisone aceponate VIRBAC S.A. 1ère Avenue 2065 m L.I.D F-06516 Carros EU/2/06/069/001 Cutaneous spray, solution QD07AC 11.1.2007 11.1.2007 Yposane Osaterone acetate VIRBAC S.A. 1ère Avenue 2065 m L.I.D F-06516 Carros EU/2/06/068/001-004 Tablets QG04CX 15.1.2007 15.1.2007 Meloxicam CEVA Meloxicam CEVA SANTE ANIMALE Z.I. la Ballastière F-33500 Libourne EU/2/06/070/001-003 oral suspension QM01AC06 18.1.2007

— Modification of a marketing authorization (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 authorization Number of the entry in the Community Register Date of notification 4.1.2007 Previcox Merial 29, avenue Tony Garnier F-69007 Lyon EU/2/04/045/001-006 9.1.2007 16.1.2007 Equilis StrepE Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/04/043/001 18.1.2007 11.1.2007 Gonazon Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/03/040/002 15.1.2007 16.1.2007 Profender Bayer HealthCare AG D-51368 Leverkusen EU/2/05/054/001-017 18.1.2007

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.