SL Uradni list Evropske unije C 334/32

Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 1. novembra 2005 do 19. novembra 2005

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

(2005/C 334/06)

— 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 7.11.2005 Abilify Otsuka Pharmaceutical Europe Ltd, Commonwealth House, 2 Chalkhill Road, Hammersmith, London W6 8DW, United Kingdom EU/1/04/276/001-032 9.11.2005 7.11.2005 Kivexa Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/04/298/001-002 9.11.2005 7.11.2005 Ziagen Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/99/112/001-002 9.11.2005 7.11.2005 Rapamune Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/01/171/001-012 9.11.2005 7.11.2005 Xagrid Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom EU/1/04/295/001 9.11.2005 7.11.2005 Emend Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/03/262/001-006 9.11.2005 15.11.2005 Levitra Bayer AG, D-51368 Leverkusen EU/1/03/248/001-012 18.11.2005 15.11.2005 Cialis - Lilly ICOS Limited, St Bride's House — 10 Salisbury Square — London EC4Y 8EH — United Kingdom EU/1/02/237/001-005 18.11.2005 15.11.2005 Taxotere Aventis Pharma SA, 20 avenue Raymond Aron, F-92165 Antony Cedex EU/1/95/002/001-002 18.11.2005 15.11.2005 NeuroBloc Solstice Neurosciences Ltd, Fitzwilton House, Wilton Place, Dublin 2, Ireland EU/1/00/166/001-003 21.11.2005 15.11.2005 Vivanza — Bayer AG, D-51368 Leverkusen EU/1/03/249/001-012 18.11.2005 15.11.2005 Viagra Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/98/077/001-012 18.11.2005 15.11.2005 PegIntron Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel EU/1/00/131/001-050 18.11.2005 15.11.2005 CellCept Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/005/001-006 18.11.2005 15.11.2005 Ebixa H. Lundbeck A/S, Ottiliavej 9, DK-2500 Valby EU/1/02/219/001-013 18.11.2005 15.11.2005 Arava Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main EU/1/99/118/001-010 18.11.2005 15.11.2005 Avandamet SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex,TW8 9GS United Kingdom EU/1/03/258/001-014 18.11.2005 15.11.2005 Xigris Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland EU/1/02/225/001-002 18.11.2005 15.11.2005 Emtriva Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom EU/1/03/261/001-003 18.11.2005 15.11.2005 Viramune Boehringer Ingelheim International GmbH, Binger Strasse 173- D — 55216 Ingelheim am Rhein EU/1/97/055/001-003 18.11.2005 15.11.2005 Tracleer Actelion Registration Ltd, BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/220/001-005 18.11.2005 15.11.2005 Viraferonpeg Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel EU/1/00/132/001-050 18.11.2005 15.11.2005 Zevalin Schering AG, Müllerstrasse 170-178, D — 13342 Berlin EU/1/03/264/001 18.11.2005 15.11.2005 Ariclaim Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein EU/1/04/283/001-007 18.11.2005 15.11.2005 Mabthera Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/98/067/001-002 18.11.2005 15.11.2005 Advate Baxter AG, Industriestraße 67, A-1221 Wien EU/1/03/271/001-004 18.11.2005 15.11.2005 Temodal Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles EU/1/98/096/001-008 18.11.2005 15.11.2005 Somavert Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/02/240/001-004 23.11.2005 15.11.2005 Axura Merz Pharmaceuticals GmbH, Eckenheimer Landstr. 100-104, D-60318 Frankfurt/Main EU/1/02/218/001-011 18.11.2005 16.11.2005 NovoSeven Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd EU/1/96/006/001-003 21.11.2005 16.11.2005 Truvada Gilead Sciences International Limited, Granta Park Abington Cambridge CB1 6GT United Kingdom EU/1/04/305/001 18.11.2005 17.11.2005 Lyrica PFIZER Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/04/279/001-032 18.11.2005 17.11.2005 Integrilin Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/99/109/001-002 21.11.2005 17.11.2005 Yentreve Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/280/001-007 21.11.2005 17.11.2005 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 21.11.2005 17.11.2005 REYATAZ Bristol — Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom EU/1/03/267/001-007 21.11.2005 17.11.2005 Panretin Ligand Pharmaceuticals UK Ltd, Innovis House, 108 High Street, Crawley, West Sussex RH10 1BB, United Kingdom EU/1/00/149/001 21.11.2005 17.11.2005 Agenerase Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/00/148/001-004 21.11.2005 17.11.2005 Infanrix Hexa GlaxoSmithKline Biologicals SA, rue de l'Institut 89, B-1330 Rixensart EU/1/00/152/001-018 21.11.2005 17.11.2005 Infanrix Penta GlaxoSmithKline Biologicals SA, rue de l'Institut 89, B-1330 Rixensart EU/1/00/153/001-010 21.11.2005 17.11.2005 Emselex Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/04/294/001-028 21.11.2005

— Začasni odvzem dovoljenja za promet (člen 18 Uredbe Sveta (EGS) št. 2309/93)

Datum odločbe Ime zdravila Imetnik dovoljenja za promet Številka vpisa v register Skupnosti Datum priglasitve 17.11.2005 Hexavac Sanofi Pasteur MSD, SNC, 8, rue Jonas Salk, F-69007 Lyon EU/1/00/147/001-012 21.11.2005

— 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 17.11.2005 Pruban Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/00/024/001 21.11.2005

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.