SL Uradni list Evropske unije C 268/2

Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 1. septembra 2005 do 30. septembra 2005

(Objavljeno na podlagi člena 12 oziroma člena 34 Uredbe Sveta (EGS) št. 2309/93 (1)

(2005/C 268/02)

— Izdaja dovoljenja za promet (člen 12 Uredbe Sveta (EGS) št. 2309/93): Odobrena

Datum odločbe Ime zdravila Imetnik dovoljenja za promet Številka vpisa v register Skupnosti Datum priglasitve 19.9.2005 Tarceva Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY EU/1/05/311/001-003 21.9.2005

— Sprememba dovoljenja za promet (člen 12 Uredbe Sveta (EGS) št. 2309/93): Odobrena

Datum odločbe Ime zdravila Imetnik dovoljenja za promet Številka vpisa v register Skupnosti Datum priglasitve 5.9.2005 Ventavis Schering AG, Müllerstraße 170-178, DE-13342 Berlin EU/1/03/255//001-003 8.9.2005 5.9.2005 Trazec Novartis Europharm Limited, Wimblehurst Road, Horsham, UK-West Sussex RH12 5AB EU/1/01/175/001-021 8.9.2005 5.9.2005 Forsteo Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten EU/1/03/247/001-002 7.9.2005 5.9.2005 Starlix Novartis Europharm Limited, Wimblehurst Road, Horsham, UK-West Sussex RH12 5AB EU/1/01/174/001-021 8.9.2005 7.9.2005 DaTSCAN GE Healthcare Limited, UK-Little Chalfont Bucks HP7 9NA EU/1/00/135/001-002 9.9.2005 7.9.2005 Emtriva Gilead Sciences International Limited, UK-Cambridge CB1 6GT EU/1/03/261/001-003 9.9.2005 7.9.2005 KOGENATE Bayer Bayer AG, DE-51368 Leverkusen EU/1/00/143/001-006 9.9.2005 7.9.2005 Helixate NexGen Bayer AG, DE-51368 Leverkusen EU/1/00/144/001-003 9.9.2005 8.9.2005 Nespo Dompé Biotec S.p.A., Via San Martino, 12, IT-20122 Milano EU/1/01/184/001-056 13.9.2005 8.9.2005 Herceptin Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY EU/1/00/145/001 13.9.2005 8.9.2005 Xagrid Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, UK-Hampshire RG24 8EP EU/1/04/295/001 13.9.2005 8.9.2005 Kivexa Glaxo Group Ltd, Berkeley Avenue, Greenford, UK-Middlesex UB6 0NN EU/1/04/298/001-002 13.9.2005 8.9.2005 Ziagen Glaxo Group Ltd, Greenford, UK-Middlesex UB6 0NN EU/1/99/112/001-002 13.9.2005 8.9.2005 Aranesp Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda EU/1/01/185/001-056 13.9.2005 8.9.2005 Karvezide Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, UK-Uxbridge UD8 1DH EU/1/98/085/001-020 13.9.2005 8.9.2005 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France, FR-75013 Paris EU/1/98/086/001-020 13.9.2005 8.9.2005 PegIntron Schering Plough Europe, Rue de Stalle, 73, BE-1180 Bruxelles — Stallestraat, 73, BE-1180 Brussel EU/1/00/131/001-050 13.9.2005 8.9.2005 ViraferonPeg Schering Plough Europe, Rue de Stalle, 73, BE-1180 Bruxelles — Stallestraat, 73, BE-1180 Brussel EU/1/00/132/001-050 13.9.2005 8.9.2005 Raptiva Serono Europe Limited, 56, Marsh Wall, UK-London E14 9TP EU/1/04/291/001-002 14.9.2005 8.9.2005 Pylobactell Torbet Laboratories Limited, Unit 14D, Wendover Road, Rackheath Industrial Estate, Norwich, UK-Norfolk NR13 6LH EU/1/98/064/001 13.9.2005 13.9.2005 Infanrix Hexa GlaxoSmithKline Biologicals S.A., rue de l'Institut 89, BE-1330 Rixensart EU/1/00/152/001-018 14.9.2005 13.9.2005 Somavert Pfizer Limited, Sandwich, UK-Kent, CT13 9NJ EU/1/02/240/001-004 14.9.2005 13.9.2005 Hepsera Gilead Sciences International Limited, UK-Cambridge CB1 6GT EU/1/03/251/001 15.9.2005 13.9.2005 Erbitux Merck KGaA, Frankfurter Straße 250, DE-64293 Darmstadt EU/1/04/281/001 14.9.2005 13.9.2005 Dynepo Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, UK-Hampshire RG24 8EP Aventis Pharma S.A., 20 Avenue Raymond Aron, Antony Cedex FR-92165 EU/1/02/211/001-009 15.9.2005 13.9.2005 Infanrix Penta GlaxoSmithKline Biologicals s.a., rue de l'Institut 89, BE-1330 Rixensart EU/1/00/153/001-010 14.9.2005 13.9.2005 Mimpara Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda EU/1/04/292/001-012 14.9.2005 13.9.2005 Avandamet SmithKline Beecham plc, 980 Great West Road, Brentford, UK-Middlesex TW8 9GS EU/1/03/258/013-014 14.9.2005 13.9.2005 Karvea Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, UK-Hounslow TW3 3JA EU/1/97/049/001-030 15.9.2005 13.9.2005 Keppra UCB S.A., Allée de la recherche, 60, BE-1070 Bruxelles — Researchdreef, 60, BE-1070 Brussel EU/1/00/146/001-029 16.9.2005 13.9.2005 Keppra UCB S.A., Allée de la recherche, 60, BE-1070 Bruxelles — Researchdreef, 60, BE-1070 Brussel EU/1/00/146/001-027 16.9.2005 13.9.2005 Aprovel Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France, FR-75013 Paris EU/1/97/046/001-030 15.9.2005 15.9.2005 Hepsera Gilead Sciences International Limited, UK-Cambridge CB1 6GT EU/1/03/251/001 20.9.2005 15.9.2005 Cymbalta Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten EU/1/04/296/001-006 20.9.2005 15.9.2005 Ariclaim Boehringer Ingelheim International GmbH, Binger Straße 173, DE-55216 Ingelheim am Rhein EU/1/04/283/001-007 20.9.2005 15.9.2005 Yentreve Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten EU/1/04/280/001-007 20.9.2005 15.9.2005 Xeristar Boehringer Ingelheim International GmbH, Binger Straße 173, DE-55216 Ingelheim am Rhein EU/1/04/297/001-006 20.9.2005 15.9.2005 Bonviva Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY EU/1/03/265/003-004 20.9.2005 15.9.2005 Bondenza Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY EU/1/03/266/003-004 20.9.2005 15.9.2005 Myocet Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, IE-County Clare EU/1/00/141/001 20.9.2005 15.9.2005 NovoMix Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd EU/1/00/142/004-005 EU/1/00/142/009-010 20.9.2005 16.9.2005 REYATAZ Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, UK-Hounslow TW3 3JA EU/1/03/267/001-007 20.9.2005 19.9.2005 Ariclaim Boehringer Ingelheim International GmbH, Binger Straße 173, DE-55216 Ingelheim am Rhein EU/1/04/283/001-007 21.9.2005 19.9.2005 Arava Aventis Pharma Deutschland GmbH, DE-65926 Frankfurt am Main EU/1/99/118/001-010 21.9.2005 19.9.2005 Yentreve Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten EU/1/04/280/001-007 21.9.2005 19.9.2005 Hexavac Sanofi Pasteur MSD, SNC, 8, rue Jonas Salk, FR-69007 Lyon EU/1/00/147/001-012 21.9.2005 22.9.2005 Iscover Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, UK-Uxbridge UD8 1DH EU/1/98/070/001a — 001b EU/1/98/070/002a — 002b EU/1/98/070/003a — 003b EU/1/98/070/004a — 001b 26.9.2005 22.9.2005 Plavix Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France, FR-75013 Paris EU/1/98/069/001a — 001b EU/1/98/069/002a — 002b EU/1/98/069/003a — 003b EU/1/98/069/004a — 001b 26.9.2005 29.9.2005 Remicade Centocor B.V., Einsteinweg 101, NL-2333 CB Leiden EU/1/99/116/001-003 4.10.2005

— Preklic dovoljenja za promet (člen 12 Uredbe Sveta (EGS) št. 2309/93)

Datum odločbe Ime zdravila Imetnik dovoljenja za promet Številka vpisa v register Skupnosti Datum priglasitve 22.9.2005 CEA-Scan Immunomedics GmbH, Otto-Röhm-Straße 69, DE-64293 Darmstadt EU/1/96/023/001 27.9.2005

— Sprememba dovoljenja za promet (člen 34 Uredbe Sveta (EGS) št. 2309/93): Odobrena

Datum odločbe Ime zdravila Imetnik dovoljenja za promet Številka vpisa v register Skupnosti Datum priglasitve 19.9.2005 Pirsue PFIZER Ltd, Ramsgate Road, Sandwich, UK-Kent CT13 9NJ EU/2/00/027/001-003 21.9.2005

Kdor želi dostop do javnega poročila o oceni zadevnih zdravil in do odločb, ki se nanje nanašajo, se lahko obrne na naslednji naslov:

The European Medicines Agency 7, Westferry Circus, Canary Wharf UK-LONDON E14 4HB

(1) UL L 214 z dne 24. avgusta 1993, stran 1.