25.2.2005 |
ET |
Euroopa Liidu Teataja |
C 49/2 |
Kokkuvõte ühenduse otsustest müügilubade kohta, mis käsitlevad ravimeid alates 15. jaanuarist 2005 kuni 15. veebruarini 2005
(Avaldatud vastavalt nõukogu määruse (EMÜ) nr 2309/93 (1) artiklile 12 või artiklile 34)
(2005/C 49/02)
— Müügiloa väljaandmine (nõukogu määruse (EMÜ) nr 2309/93 artikkel 12) Luba antud
Otsuse kuupäev |
Ravimi nimetus |
Müügiloa omanik |
Kande number ühenduse registris |
Teate kuupäev |
2.2.2005 |
Fendrix |
GlaxoSmithKline Biologicals S.A., rue de l'Institut 89, 1330 Rixensart, Belgique |
EU/1/04/299/001-003 |
4.2.2005 |
— Müügiloa muutmine (nõukogu määruse (EMÜ) nr 2309/93 artikkel 12) Luba antud
Otsuse kuupäev |
Ravimi nimetus |
Müügiloa omanik |
Kande number ühenduse registris |
Teate kuupäev |
20.1.2005 |
Norvir |
Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom |
EU/1/96/016//001 EU/1/96/016/003 |
24.1.2005 |
20.1.2005 |
Zerit |
Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom |
EU/1/96/009/001-017 |
24.1.2005 |
20.1.2005 |
Avandamet |
SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex,TW8 9GS United Kingdom |
EU/1/03/258/001-012 |
24.1.2005 |
20.1.2005 |
Zerit |
Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom |
EU/1/96/009/001-017 |
24.1.2005 |
20.1.2005 |
Rapamune |
Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
EU/1/01/171/011-012 |
24.1.2005 |
25.1.2005 |
NeupoPeg |
Dompé Biotec S.p.A., Via San Martino, 12, I – 20122 Milano, Italia |
EU/1/02/228/001-002 |
27.1.2005 |
25.1.2005 |
Neulasta |
Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, Nederland |
EU/1/02/227/001-002 |
27.1.2005 |
25.1.2005 |
IntronA |
Schering Plough Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique |
EU/1/99/127/001-044 |
28.1.2005 |
25.1.2005 |
Viraferon |
Schering Plough Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique |
EU/1/99/128/001-037 |
28.1.2005 |
25.1.2005 |
Xigris |
Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA Houten, Nederland |
EU/1/02/225/001-002 |
27.1.2005 |
25.1.2005 |
Trudexa |
Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom |
EU/1/03/257/001-006 |
27.1.2005 |
25.1.2005 |
Arixtra |
Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom |
EU/1/02/206/001-017 |
27.1.2005 |
25.1.2005 |
Travatan |
Alcon Laboratories (UK) Ltd., Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom |
EU/1/01/199/001-002 |
27.1.2005 |
25.1.2005 |
Quixidar |
Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom |
EU/1/02/206/001-017 |
27.1.2005 |
25.1.2005 |
Humira |
Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom |
EU/1/03/256/001-006 |
27.1.2005 |
25.1.2005 |
Rebetol |
Schering Plough Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique – Stallestraat, 73 – 1180 Brussel, België è |
EU/1/99/107/001-004 |
27.1.2005 |
25.1.2005 |
Rebetol |
Schering Plough Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique – Stallestraat, 73 – 1180 Brussel, België è |
EU/1/99/107/004 |
27.1.2005 |
26.1.2005 |
Remicade |
Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland |
EU/1/99/116/001-003 |
28.1.2005 |
26.1.2005 |
Bextra |
Pharmacia-Pfizer EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom |
EU/1/02/239/001-030 |
1.2.2005 |
26.1.2005 |
Dynastat |
Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United-Kingdom |
EU/1/02/209/001-008 |
1.2.2005 |
26.1.2005 |
Rayzon |
Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United-Kingdom |
EU/1/02/210/001-008 |
1.2.2005 |
26.1.2005 |
Prevenar |
Wyeth-Lederle Vaccines S.A., Rue du Bosquet, 15 – 1348 Louvain-La-Neuve - Belgique. |
EU/1/00/167/001-007 |
28.1.2005 |
26.1.2005 |
Valdyn |
Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom |
EU/1/02/244/001-024 |
31.1.2005 |
26.1.2005 |
Visudyne |
Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom. |
EU/1/00/140/001 |
31.1.2005 |
26.1.2005 |
Pegasys |
Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom |
EU/1/02/221/001-008 |
31.1.2005 |
26.1.2005 |
Renagel |
Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland |
EU/1/99/123/001-011 |
28.1.2005 |
31.1.2005 |
Tractocile |
Ferring AB, Soldattorpsvägen 5 - Box 30 047, Limhamn 20061, Sverige |
EU/1/99/124/001-002 |
2.2.2005 |
2.2.2005 |
NovoNorm |
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark |
EU/1/98/076/001-002, EU/1/98/076/004-009, EU/1/98/076/011-016 EU/1/98/076/018-021 |
4.2.2005 |
4.2.2005 |
Prandin |
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark |
EU/1/00/162/001-018 |
8.2.2005 |
9.2.2005 |
Zyprexa |
Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland |
EU/1/96/022/016-018 |
11.2.2005 |
9.2.2005 |
Zyprexa |
Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland |
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 |
11.2.2005 |
9.2.2005 |
Zyprexa Velotab |
Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland |
EU/1/99/125/001-008 |
11.2.2005 |
14.2.2005 |
Keppra |
UCB S.A. - Allée de la recherche, 60, Bruxelles 1070, Belgique/ Researchdreef, 60, Brussel 1070, België |
EU/1/00/146/001-029 |
16.2.2005 |
14.2.2005 |
Avonex |
Biogen Idec Ltd, 5 Roxborough Way, Foundation Park, Maidenhead, Berkshire, SL6 3UD, United Kindgom Biogen Idec France, “Le Capitole” 55, avenue des Champs Pierreux - 92012 Nanterre Cedex - France. |
EU/1/97/033/001-003 |
16.2.2005 |
14.2.2005 |
Helicobacter Test INFAI |
INFAI, Institut für biomedizinische Analytic und NMR Imaging GmbH - Universitätsstrasse 142, D - 44799 Bochum, Germany |
EU/1/97/045/001-004 |
16.2.2005 |
15.2.2005 |
Karvea |
Bristol-Myers Squibb Pharma EEIG - 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom |
EU/1/97/049/001-030 |
17.2.2005 |
15.2.2005 |
Aprovel |
Sanofi Pharma Bristol-Myers Squibb SNC - 174 avenue de France - 75013 Paris, France |
EU/1/97/046/001-030 |
17.2.2005 |
— Müügiloa muutmine (nõukogu määruse (EMÜ) nr 2309/93 artikkel 34) Luba antud
Otsuse kuupäev |
Ravimi nimetus |
Müügiloa omanik |
Kande number ühenduse registris |
Teate kuupäev |
31.1.2005 |
IBAFLIN |
Intervet International B.V., Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
EU/2/00/022/001a-001b, 002a - 002b, 003a-003b, 004a-004b EU/2/00/022/005-008, |
2.2.2005 |
31.1.2005 |
METACAM |
Boehringer Ingelheim Vetmedica GmbH, 55216 Ingelheim am Rhein, Deutschland |
EU/2/97/004/007-008 |
2.2.2005 |
(1) EÜT L 214, 24.8.1993, lk 1