EN Official Journal of the European Union C 92/15

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2007 to 31 March 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 92/15)

— 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 21.3.2007 Daronrix A/Viet Nam/1194/2004 (H5N1) whole virus inactivated antigen GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/06/381/001-008 Suspension for injection J07BB01 23.3.2007 21.3.2007 Xelevia sitagliptin Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/07/382/001-018 Film-coated tablets A10BH01 23.3.2007 21.3.2007 Januvia sitagliptin Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/07/383/001-018 Film-coated tablets A10BH01 23.3.2007

— 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 1.3.2007 Kinzalmono Bayer HealthCare AG D-51368 Leverkusen EU/1/98/091/001-014 5.3.2007 1.3.2007 Epivir Glaxo Group Ltd, Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/96/015/001-005 5.3.2007 1.3.2007 Xyrem UCB Pharma Ltd 208 Bath Road Slough Berks SL1 3WE United Kingdom EU/1/05/312/001 5.3.2007 1.3.2007 Integrilin Glaxo Group Ltd Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom EU/1/99/109/001-002 5.3.2007 1.3.2007 PEGASYS Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/221/001-010 5.3.2007 1.3.2007 Truvada Gilead Sciences International Limited Granta Park Abington Cambridge CB1 6GT United Kingdom EU/1/04/305/001 5.3.2007 1.3.2007 Travatan Alcon Laboratories (UK) Ltd Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom EU/1/01/199/001-002 5.3.2007 5.3.2007 Kinzalkomb Bayer HealthCare AG D-51368 Leverkusen EU/1/02/214/001-010 7.3.2007 5.3.2007 MicardisPlus Boehringer Ingelheim International GmbH Binger Straβe 173 D-55216 Ingelheim am Rhein EU/1/02/213/001-016 7.3.2007 5.3.2007 Humira Abbott laboratories Ltd, Queenborough Kent ME11 5EL United Kingdom EU/1/03/256/001-010 7.3.2007 5.3.2007 NovoSeven Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/96/006/001-003 8.3.2007 5.3.2007 Trudexa Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/03/257/001-010 7.3.2007 5.3.2007 Metalyse Boehringer Ingelheim International GmbH Binger Straβe 173 D-55216 Ingelheim am Rhein EU/1/00/169/004-006 7.3.2007 5.3.2007 Refludan Pharmion Limited Riverside House Riverside Walk Windsor SL4 1NA United Kingdom EU/1/97/035/001-004 7.3.2007 5.3.2007 Micardis Boehringer Ingelheim International GmbH Binger Straβe 173 D-55216 Ingelheim am Rhein EU/1/98/090/001-020 7.3.2007 5.3.2007 Corlentor Les Laboratoires Servier 22, rue Garnier F-92200 Neuilly-sur-Seine EU/1/05/317/001-014 7.3.2007 6.3.2007 Aprovel Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France F-75013 Paris EU/1/97/046/001-033 8.3.2007 6.3.2007 Karvea Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/97/049/001-033 8.3.2007 6.3.2007 Procolaran Les Laboratoires Servier 22, rue Garnier F-92200 Neuilly-sur-Seine EU/1/05/316/001-014 8.3.2007 6.3.2007 Bondronat Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/012/004 EU/1/96/012/009-013 8.3.2007 6.3.2007 Onsenal Pharmacia-Pfizer EEIG Ramsgate Road Sanwich CT13 9NJ United Kingdom EU/1/03/259/001-006 8.3.2007 7.3.2007 Angiox The Medicines Company UK Ltd Suite B Park House 11 Milton Park Abingdon Oxfordshire OX14 4RS United Kingdom EU/1/04/289/001-002 9.3.2007 9.3.2007 Prevenar Wyeth-Lederle Vaccines S.A. Rue du Bosquet, 15 B-1348 Louvain-La-Neuve EU/1/00/167/001-007 13.3.2007 9.3.2007 Savene TopoTarget A/S Fruebjergvej 3 DK-2100 København Ø EU/1/06/350/001 13.3.2007 9.3.2007 Herceptin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/00/145/001 13.3.2007 14.3.2007 Synagis Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/99/117/001-002 16.3.2007 14.3.2007 Alimta Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/04/290/001 16.3.2007 14.3.2007 Liprolog Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/01/195/001-015 16.3.2007 14.3.2007 Vasovist Schering AG Müllerstraβe 172-178 D-13342 Berlin EU/1/05/313/001-009 16.3.2007 20.3.2007 Kineret Amgen Europe BV Minervum 7061 4817 ZK Breda Nederland EU/1/02/203/001-004 22.3.2007 20.3.2007 GONAL-f Serono Europe Limited 56 Marsh Wall London E14 9TP United Kingdom EU/1/95/001/033-035 23.3.2007 21.3.2007 Aptivus Boehringer Ingelheim International GmbH Binger Straβe 173 D-55216 Ingelheim am Rhein EU/1/05/315/001 23.3.2007 21.3.2007 Invanz Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/02/216/001-002 23.3.2007 23.3.2007 Emselex Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/04/294/001-028 27.3.2007 27.3.2007 Zimulti Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/06/345/001-009 29.3.2007 27.3.2007 ACOMPLIA Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/06/344/001-009 29.3.2007 27.3.2007 Emtriva Gilead Sciences International Limited Cambridge CB1 6GT United Kingdom EU/1/03/261/001-003 29.3.2007 27.3.2007 Avastin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/04/300/001-002 29.3.2007 27.3.2007 Mabthera Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/98/067/001-002 29.3.2007 27.3.2007 Remicade Centocor BV Einsteinweg 101 2333 CB Leiden Nederland EU/1/99/116/001-003 29.3.2007 27.3.2007 Liprolog Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/01/195/001-015 29.3.2007 27.3.2007 REYATAZ Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/03/267/001-007 29.3.2007 27.3.2007 Optruma Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/98/074/001-004 30.3.2007 28.3.2007 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom EU/1/04/295/001 30.3.2007 28.3.2007 Xeloda Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom EU/1/00/163/001-002 30.3.2007 28.3.2007 Kaletra Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/01/172/001-005 30.3.2007 28.3.2007 Rebif Serono Europe Ltd 56 Marsh Wall London E14 9TP United Kingdom EU/1/98/063/001-007 30.3.2007 28.3.2007 Evista Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/98/073/001-004 30.3.2007 28.3.2007 Glivec Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/01/198/001-013 30.3.2007 28.3.2007 NeuroBloc Solstice Neurosciences Ltd Fitzwilton House Wilton Place Dublin 2 Ireland EU/1/00/166/001-003 30.3.2007 28.3.2007 Zonegran Eisai Limited 3 Shortlands London W6 8EE United Kingdom EU/1/04/307/001-013 30.3.2007 28.3.2007 Tamiflu Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/222/001-002 30.3.2007 28.3.2007 Humalog Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/96/007/002 EU/1/96/007/004 EU/1/96/007/011 EU/1/96/007/015 EU/1/96/007/020-021 EU/1/96/007/023 EU/1/96/007/026 30.3.2007 29.3.2007 Humalog Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/96/007/002 EU/1/96/007/004-006 EU/1/96/007/008 EU/1/96/007/010-011 EU/1/96/007/015-021 EU/1/96/007/023-030 2.4.2007 29.3.2007 Dynastat Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom EU/1/02/209/001-008 2.4.2007 29.3.2007 DaTSCAN GE Healthcare Limited Little Chalfont Bucks HP7 9NA United Kingdom EU/1/00/135/001-002 2.4.2007 29.3.2007 InductOs Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire, SL6 0PH United Kingdom EU/1/02/226/001 2.4.2007 29.3.2007 Betaferon Schering Aktiengesellschaft D-13342 Berlin EU/1/95/003/003-006 2.4.2007 29.3.2007 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 4.4.2007 29.3.2007 Invirase Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/026/001-002 2.4.2007 29.3.2007 Revatio Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/05/318/001 4.4.2007

— 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 14.3.2007 Previcox Merial 29 avenue Tony Garnier F-69007 Lyon EU/2/04/045/007 16.3.2007 14.3.2007 Nobivac Piro Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/04/046/001-003 16.3.2007

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.