26.11.2004 |
FI |
Euroopan unionin virallinen lehti |
C 289/7 |
Yhteenveto yhteisön päätöksistä markkinoille saattamista koskevien lupien osalta 15.10.2004—15.11.2004
(Neuvoston asetuksen (ETY) N:o 2309/93 (1) 12 ja 34 artiklan mukaisesti julkaistu ilmoitus)
(2004/C 289/07)
Luvan myöntäminen (Neuvoston asetuksen (ETY) N:o 2309/93 (1) 12 artikla) — Hyväksytty
Päätöksen päivämäärä |
Lääkkeen nimi |
Luvan haltija |
Numero yhteisön lääkerekisterissä |
Ilmoitus päivämäärä |
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 |
Luvan muuttaminen (Neuvoston asetuksen (ETY) N:o 2309/93 12 artikla) — Hyväksytty
Päätöksen päivämäärä |
Lääkkeen nimi |
Luvan haltija |
Numero yhteisön lääkerekisterissä |
Ilmoitus päivämäärä |
||
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) EYVL L 214, 24.8.1993, s.1