SL Uradni list Evropske unije C 104/15

Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 15. marca 2005 do 15. aprila 2005

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

(2005/C 104/04)

— 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 22.3.2005 Aloxi Helsinn Birex Pharmaceuticals Ltd, Damastown, Mulhuddart, Dublin 15, Republic of Ireland EU/1/04/306/001 24.3.2005 15.4.2005 Aclasta Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/308/001 19.4.2005

— 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 16.3.2005 Thyrogen Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland EU/1/99/122/001-002 18.3.2005 22.3.2005 Zometa Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/176/001-006 24.3.2005 22.3.2005 PegIntron Schering Plough Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique – Stallestraat, 73 – 1180 Brussel, België EU/1/00/131/001-050 24.3.2005 22.3.2005 ViraferonPeg Schering Plough Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique – Stallestraat, 73 – 1180 Brussel, België EU/1/00/132/001-050 24.3.2005 22.3.2005 Aldurazyme Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland EU/1/03/253/001-003 24.3.2005 29.3.2005 Foscan Biolitec pharma (Ireland) Ltd., Unit 2, Broomhill Business Park, Broomhill Road,Tallaght, Dublin 24, Ireland EU/1/01/197/001-002 1.4.2005 29.3.2005 Cialis Lilly ICOS Limited, St Bride's House – 10 Salisbury Square – London EC4Y 8EH – United Kingdom. EU/1/02/237/001-005 31.3.2005 29.3.2005 Inductos Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/02/226/001 31.3.2005 29.3.2005 Ammonaps Orphan Europe, Immeuble „Le Guillaumet“, F-92046 Paris La Défense, France EU/1/99/120/001-004 31.3.2005 29.3.2005 NeuroBloc Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, County Clare, Ireland EU/1/00/166/001-003 4.4.2005 29.3.2005 Levitra Bayer AG, D-51368 Leverkusen, Deutschland EU/1/03/248/001-012 31.3.2005 29.3.2005 Vivanza Bayer AG, D-51368 Leverkusen, Deutschland EU/1/03/249/001-012 31.3.2005 29.3.2005 Uprima Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom EU/1/01/180/001-010 31.3.2005 29.3.2005 Viagra Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/98/077/001-012 31.3.2005 29.3.2005 Vfend Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/212/001-026 31.3.2005 29.3.2005 Mirapexin Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/97/051/001-006 EU/1/97/051/009-012 31.3.2005 29.3.2005 Stalevo Orion Corporation, Orionintie 1, FIN-02200 Espoo, Suomi EU/1/03/260/001-012 31.3.2005 29.3.2005 Zeffix Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/99/114/001-003 31.03.2005 29.3.2005 Levemir Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/04/278/001-009 31.3.2005 29.3.2005 Visudyne Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/00/140/001 31.3.2005 29.3.2005 HBVAXPRO Aventis Pasteur MSD, 8, rue Jonas Salk, 69007 Lyon, France EU/1/01/183/019 31.3.2005 30.3.2005 Xeloda Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/00/163/001-002 01.04.2005 30.3.2005 NovoRapid Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/99/119/001 EU/1/99/119/003 EU/1/99/119/005-014 1.4.2005 30.3.2005 Glivec Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/198/001-013 1.4.2005 30.3.2005 Bondenza Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/03/266/001-002 1.4.2005 30.3.2005 Sifrol Boehringer Ingelheim International GmbH, Binger Strasse 173 – D-55216 Ingelheim am Rhein, Deutschland EU/1/97/050/001-006 EU/1/97/050/009-012 1.4.2005 30.3.2005 Abilify Otsuka Pharmaceutical Europe Ltd, Commonwealth House, 2 Chalkhill Road, Hammersmith, London W6 8DW, United Kingdom EU/1/04/276/001-020 1.4.2005 30.3.2005 EMEND Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/03/262/001-006 1.4.2005 11.4.2005 Cerezyme Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland EU/1/97/053/001-005 13.4.2005 11.4.2005 Fuzeon Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/03/252/001-002 13.4.2005

— 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 16.3.2005 Eurifel FeLV Merial, 29 Avenue Tony Garnier, 69007 Lyon, France EU/2/00/019/005-007 18.3.2005 11.4.2005 Incurin Intervet International B.V., Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/00/018/001 14.4.2005 11.4.2005 Rabigen SAG2 VIRBAC S.A., 1ere Avenue 2065 m L.I.D. – 06516 Carros – France EU/2/00/021/001-002 13.4.2005 15.4.2005 Aivlosin ECO Animal Health Ltd, 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom EU/2/04/044/001 19.4.2005

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, 24.8.1993, str. 1.