This document is an excerpt from the EUR-Lex website
Document 52004XC1126(01)
Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 October 2004 to 15 November 2004 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 15. oktobra 2004 do 15. novembra 2004 (Objavljeno na podlagi člena 12 oziroma člena 34 Uredbe Sveta (EGS) št. 2309/93)
Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 15. oktobra 2004 do 15. novembra 2004 (Objavljeno na podlagi člena 12 oziroma člena 34 Uredbe Sveta (EGS) št. 2309/93)
UL C 289, 26.11.2004, p. 7–9
(ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)
|
26.11.2004 |
SL |
Uradni list Evropske unije |
C 289/7 |
Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 15. oktobra 2004 do 15. novembra 2004
(Objavljeno na podlagi člena 12 oziroma člena 34 Uredbe Sveta (EGS) št. 2309/93 (1))
(2004/C 289/07)
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 |
|
22.10.2004 |
EMSELEX |
Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
EU/1/04/294/001-012 |
26.10.2004 |
|
22.10.2004 |
Mimpara |
Amgen Europe BV, Minervum 7061, 4817 ZK Breda, The Netherlands |
EU/1/04/292/001-012 |
26.10.2004 |
|
22.10.2004 |
Parareg |
Amgen Europe BV, Minervum 7061, 4817 ZK Breda, The Netherlands |
EU/1/04/293/001-012 |
26.10.2004 |
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 |
||
|
20.10.2004 |
Zeffix |
Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom |
EU/1/99/114/001-003 |
22.10.2004 |
||
|
20.10.2004 |
Puregon |
Organon NV, PO box 20, 5340 BH Oss, The Netherlands |
EU/1/96/008/038-039 |
22.10.2004 |
||
|
20.10.2004 |
Viracept |
Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom |
EU/1/97/054/001 EU/1/97/054/003-006 |
22.10.2004 |
||
|
20.10.2004 |
Taxotere |
Aventis Pharma SA, 20 avenue Raymond Aron, F-92165 Antony Cedex, |
EU/1/95/002/001-002 |
22.10.2004 |
||
|
20.10.2004 |
ViraferonPeg |
Schering Plough Europe, Rue de Stalle, 73, B-1180 Brussels |
EU/1/00/132/001-050 |
22.10.2004 |
||
|
20.10.2004 |
PegIntron |
Schering Plough Europe, Rue de Stalle, 73, B-1180 BrusselsStallestraat, 73, B-1180 Brussel |
EU/1/00/131/001-050 |
22.10.2004 |
||
|
22.10.2004 |
Herceptin |
Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom |
EU/1/00/145/001 |
26.10.2004 |
||
|
22.10.2004 |
EMEND |
Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/03/262/001-006 |
26.10.2004 |
||
|
22.10.2004 |
Sifrol |
Boehringer Ingelheim International GmbH, Binger Strasse 173 D-55216 Ingelheim am Rhein |
EU/1/97/050/001-006 EU/1/97/050/009-012 |
26.10.2004 |
||
|
22.10.2004 |
Bondronat |
Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom |
EU/1/96/012/001-013 |
26.10.2004 |
||
|
28.10.2004 |
Agenerase |
Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom |
EU/1/00/148/001-004 |
1.11.2004 |
||
|
28.10.2004 |
Paxene |
Norton Healthcare Limited, Albert Basin, Royal Docks, London E16 2QJ, United Kingdom |
EU/1/99/113/001-004 |
1.11.2004 |
||
|
28.10.2004 |
Cancidas |
Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/01/196/001-003 |
1.11.2004 |
||
|
28.10.2004 |
Ziagen |
Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom |
EU/1/99/112/001-002 |
1.11.2004 |
||
|
28.10.2004 |
Ziagen |
Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom |
EU/1/99/112/001-002 |
1.11.2004 |
||
|
28.10.2004 |
Ytracis |
CIS bio international, Boite postale 32, F-91192 Gif-sur-Yvette |
EU/1/03/250/001 |
3.11.2004 |
||
|
28.10.2004 |
Mirapexin |
Boehringer Ingelheim International GmbH, Binder Strasse 173, D-55216 Ingelheim am Rhein |
EU/1/97/051/001-006 EU/1/97/051/009-012 |
1.11.2004 |
||
|
28.10.2004 |
Viraferon |
|
EU/1/99/128/001-008 |
1.11.2004 |
||
|
28.10.2004 |
CoAprovel |
Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France, F-75013 Paris |
EU/1/98/086/001-020 |
2.11.2004 |
||
|
28.10.2004 |
Karvezide |
Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom |
EU/1/98/085/001-020 |
1.11.2004 |
||
|
28.10.2004 |
Viread |
Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom |
EU/1/01/200/001 |
1.11.2004 |
||
|
28.10.2004 |
Ammonaps |
Orphan Europe, Immeuble „Le Guillaumet“, F-92046 Paris La Défense |
EU/1/99/120/001-004 |
2.11.2004 |
||
|
28.10.2004 |
IntronA |
|
EU/1/99/127/001-010 EU/1/99/127/040 |
2.11.2004 |
||
|
29.10.2004 |
PEGASYS |
Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom |
EU/1/02/221/001-010 |
5.11.2004 |
||
|
29.10.2004 |
MabCampath |
ILEX Pharmaceutical Ltd, 1 & 3 Frederick Sanger Road, The Surrey Research Park, Guildford, Surrey GU2 7YD, United Kingdom |
EU/1/01/193/002 |
5.11.2004 |
||
|
29.10.2004 |
Liprolog |
Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, The Netherlands |
EU/1/01/195/001-015 |
5.11.2004 |
||
|
4.11.2004 |
Zometa |
Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
EU/1/01/176/001-006 |
8.11.2004 |
||
|
4.11.2004 |
Zyprexa |
Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, The Netherlands |
EU/1/96/022/002, EU/1/96/022/004, EU/1/96/022/006, EU/1/96/022/008-012, EU/1/96/022/014, EU/1/96/022/016-022 |
8.11.2004 |
||
|
4.11.2004 |
Zyprexa Velotab |
Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, The Netherlands |
EU/1/99/125/001-008 |
8.11.2004 |
||
|
4.11.2004 |
Zyprexa Velotab |
Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, The Netherlands |
EU/1/99/125/001-008 |
8.11.2004 |
||
|
9.11.2004 |
Vfend |
Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/02/212/001-026 |
15.11.2004 |
||
|
12.11.2004 |
Arixtra |
Sanofi-Synthelabo 174 avenue de France, F-75013 Paris |
EU/1/02/206/009-017 |
16.11.2004 |
||
|
12.11.2004 |
Quixidar |
N.V. Organon PO box 20, Kloosterstraat 6, 5340 EB Oss, The Netherlands |
EU/1/02/207/009-017 |
16.11.2004 |
(1) UL L 214, 24.8.1993, str. 1.