SL Uradni list Evropske unije C 209/3

Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 1. julija 2005 do 31. julija 2005

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

(2005/C 209/03)

— 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 4.7.2005 Apidra Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main EU/1/04/285/001-028 6.7.2005 4.7.2005 Forcaltonin Unigene UK Limited, 63 High Road, Bushey Heath, Herts, WD2 1EE, United Kingdom EU/1/98/093/002 6.7.2005 4.7.2005 Trisenox Cell Therapeutics (UK) Ltd, 100 Pall Mall, London SW1Y 5HP, United Kingdom EU/1/02/204/001 6.7.2005 4.7.2005 Levemir Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd EU/1/04/278/001-009 6.7.2005 4.7.2005 Zerene Wyeth Research (UK) Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/099/001-006 6.7.2005 4.7.2005 Sonata Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/102/001-008 6.7.2005 4.7.2005 Cymbalta Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/296/001-006 6.7.2005 4.7.2005 Cymbalta Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/296/001-006 6.7.2005 4.7.2005 Xeristar Boehringer Ingelheim International GmbH, Binger Strasse 173 — D-55216 Ingelheim am Rhein EU/1/04/297/001-006 6.7.2005 4.7.2005 Xeristar Boehringer Ingelheim International GmbH, Binger Strasse 173 — D-55216 Ingelheim am Rhein EU/1/04/297/001-006 6.7.2005 4.7.2005 Visudyne Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/00/140/001 6.7.2005 4.7.2005 Xigris Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland EU/1/02/225/001-002 6.7.2005 7.7.2005 Invanz Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/02/216/001-002 11.7.2005 7.7.2005 Arixtra Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/02/206/001-008 11.7.2005 7.7.2005 Quixidar Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/02/207/001-008 11.7.2005 7.7.2005 Cystagon Orphan Europe, Immeuble „Le Guillaumet“, F-92046 Paris La Défense EU/1/97/039/001-004 11.7.2005 8.7.2005 Glivec Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/198/001-013 12.7.2005 8.7.2005 Aranesp Amgen Europe BV, Minervum 7061, 4817 ZK Breda, Nederland EU/1/01/185/001-056 12.7.2005 8.7.2005 Nespo Dompé Biotec SpA, Via San Martino, 12, I-20122 Milano EU/1/01/184/001-056 12.7.2005 8.7.2005 Lyrica PFIZER Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/04/279/030-032 12.7.2005 8.7.2005 Fortovase Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/98/075/001-002 12.7.2005 8.7.2005 AVANDIA SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom EU/1/00/137/001-012 12.7.2005 8.7.2005 NovoRapid Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd EU/1/99/119/003 EU/1/99/119/005-007 EU/1/99/119/009-014 12.7.2005 8.7.2005 NeuroBloc Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, County Clare, Ireland EU/1/00/166/001-003 13.7.2005 8.7.2005 Simulect Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/084/001-002 12.7.2005 8.7.2005 Zevalin Schering AG, Müllerstrasse 170-178, D-13342 Berlin EU/1/03/264/001 12.7.2005 8.7.2005 Viread Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom EU/1/01/200/001 12.7.2005 8.7.2005 Keppra UCB SA, Allée de la recherche, 60, B-1070 Bruxelles/Researchdreef, 60, B-1070 Brussel EU/1/00/146/001-027 12.7.2005 8.7.2005 Lantus Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main EU/1/00/134/001-029 12.7.2005 8.7.2005 Optisulin Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main EU/1/00/133/001-008 12.7.2005 13.7.2005 NeoRecormon Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/97/031/001-003 EU/1/97/031/019-046 15.7.2005 22.7.2005 Enbrel Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-011 26.7.2005 22.7.2005 KOGENATE Bayer Bayer AG, D-51368 Leverkusen EU/1/00/143/001-006 26.7.2005 27.7.2005 Vaniqa Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom EU/1/01/173/001-003 29.7.2005 27.7.2005 Infergen Yamanouchi Europe B.V., Elisabethhof 19, 2353 EW Leiderdorp, Nederland EU/1/98/087/001-003 29.7.2005 27.7.2005 Zevalin Schering AG, Müllerstrasse 170-178, D-13342 Berlin EU/1/03/264/001 29.7.2005 27.7.2005 Replagal TKT Europe AB, Rinkebyvägen 11B, S-182 36 Danderyd EU/1/01/189/001-006 29.7.2005 27.7.2005 Velcade Janssen-Cilag International NV, Turnhoutseweg, 30 B-2340 Beerse EU/1/04/274/001 29.7.2005 27.7.2005 AVANDIA SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom EU/1/00/137/001-012 29.7.2005 27.7.2005 ReFacto Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/103/001-004 29.7.2005 28.7.2005 Kineret Amgen Europe BV, Minervum 7061, 4817 ZK Breda, Nederland EU/1/02/203/001-004 1.8.2005

— Izdaja 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 8.7.2005 Equilis Prequenza Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/05/056/001-002 12.7.2005 8.7.2005 Equilis Prequenza Te Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/05/057/001-002 12.7.2005 8.7.2005 Equilis Te Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/05/055/001-002 12.7.2005 27.7.2005 Profender Bayer Healthcare AG, D-51368 Leverkusen EU/2/05/054/001-017 29.7.2005

— 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 7.7.2005 Neocolipor Merial, 29 avenue Tony Garnier, F-69007 Lyon EU/2/98/008/001-004 11.7.2005 8.7.2005 Ibaflin Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/00/022/001a-001b, 002a-002b, 003a-003b, 004a-004b, EU/2/00/022/005-017, 12.7.2005

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 London E14 4HB United Kingdom

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