|
29.4.2005 |
ET |
Euroopa Liidu Teataja |
C 104/15 |
Kokkuvõte ühenduse otsustest müügilubade kohta, mis käsitlevad ravimeid alates 15. märts 2005 kuni 15. aprill 2005
(Avaldatud vastavalt nõukogu määruse (EMÜ) nr 2309/93 (1) artiklile 12 või artiklile 34)
(2005/C 104/04)
— Müügiloa väljaandmine (nõukogu määruse (EMÜ) nr 2309/93 artikkel 12) Luba antud
|
Otsuse kuupäev |
Ravimi nimetus |
Müügiloa omanik |
Kande number ühenduse registris |
Teate kuupäev |
|
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 |
— Müügiloa muutmine (nõukogu määruse (EMÜ) nr 2309/93 artikkel 12) Luba antud
|
Otsuse kuupäev |
Ravimi nimetus |
Müügiloa omanik |
Kande number ühenduse registris |
Teate kuupäev |
|
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 |
31.3.2005 |
|
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 |
1.4.2005 |
|
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 |
— Müügiloa muutmine (nõukogu määruse (EMÜ) nr 2309/93 artikkel 34) Luba antud
|
Otsuse kuupäev |
Ravimi nimetus |
Müügiloa omanik |
Kande number ühenduse registris |
Teate kuupäev |
|
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 |
Kõnealuseid ravimeid käsitleva avaliku hindamisaruande ja sellega seotud otsustega tutvumiseks tuleks võtta ühendust järgmise ametiga:
|
The European Medicines Agency |
|
7, Westferry Circus, Canary Wharf |
|
UK — London E14 4HB |
(1) EÜT L 214, 24.8.1993, lk 1