Data wydania decyzji |
Nazwa produktu leczniczego |
Posiadacz pozwolenia na dopuszczenie do obrotu |
Numer wpisu w rejestrze wspólnotowym |
Data notyfikacji |
2.6.2009 |
Avamys |
Glaxo Group Ltd Greenford
Middlesex
UB6 0NN
UNITED KINGDOM
|
EU/1/07/434/001-003 |
5.6.2009 |
2.6.2009 |
Alisade |
Glaxo Group Ltd Greenford
Middlesex
UB6 ONN
UNITED KINGDOM
|
EU/1/08/474/001-003 |
5.6.2009 |
2.6.2009 |
Ketek |
Aventis Pharma S.A. 20 avenue Raymond Aron
92160 Antony
FRANCE
|
EU/1/01/191/001-005 |
5.6.2009 |
2.6.2009 |
Stocrin |
Merck Sharp & Dohme Ltd Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
UNITED KINGDOM
|
EU/1/99/111/001-005 EU/1/99/111/008-011
|
5.6.2009 |
2.6.2009 |
Velmetia |
Merck Sharp & Dohme Ltd Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
UNITED KINGDOM
|
EU/1/08/456/001-016 |
5.6.2009 |
2.6.2009 |
Ferriprox |
Apotex Europe B.V. Darwingweg 20
2333 CR Leiden
NEDERLAND
|
EU/1/99/108/001-003 |
4.6.2009 |
2.6.2009 |
Januvia |
Merck Sharp & Dohme Ltd Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
UNITED KINGDOM
|
EU/1/07/383/001-018 |
5.6.2009 |
2.6.2009 |
Janumet |
Merck Sharp & Dohme Ltd Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
UNITED KINGDOM
|
EU/1/08/455/001-016 |
5.6.2009 |
2.6.2009 |
Silgard |
Merck Sharp & Dohme Ltd Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
UNITED KINGDOM
|
EU/1/06/358/001-021 |
4.6.2009 |
2.6.2009 |
Sustiva |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park
Sanderson Road
Uxbridge
UB8 1DH
UNITED KINGDOM
|
EU/1/99/110/001-005 EU/1/99/110/008-010
|
5.6.2009 |
2.6.2009 |
Efficib |
Merck Sharp & Dohme Ltd Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
UNITED KINGDOM
|
EU/1/08/457/001-016 |
5.6.2009 |
4.6.2009 |
Avandamet |
SmithKline Beecham plc 980 Great West Road
Brentford
Middlesex
TW8 9GS
UNITED KINGDOM
|
EU/1/03/258/001-022 |
8.6.2009 |
4.6.2009 |
Ovitrelle |
Serono Europe Limited 56 Marsh Wall
London
E14 9TP
UNITED KINGDOM
|
EU/1/00/165/001-007 |
8.6.2009 |
8.6.2009 |
Tasigna |
Novartis Europharm Limited Wimblehurst Road
Horsham
West Sussex
RH12 5AB
UNITED KINGDOM
|
EU/1/07/422/001-004 |
10.6.2009 |
8.6.2009 |
Ziagen |
Glaxo Group Ltd Greenford
Middlesex
UB6 0NN
UNITED KINGDOM
|
EU/1/99/112/001-002 |
10.6.2009 |
8.6.2009 |
Pergoveris |
Serono Europe Limited 56 Marsh Wall
London
E14 9TP
UNITED KINGDOM
|
EU/1/07/396/001-003 |
10.6.2009 |
8.6.2009 |
Baraclude |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park
Sanderson Road
Uxbridge
UB8 1DH
UNITED KINGDOM
|
EU/1/06/343/001-007 |
10.6.2009 |
8.6.2009 |
REYATAZ |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park
Sanderson Road
Uxbridge
UB8 1DH
UNITED KINGDOM
|
EU/1/03/267/001-010 |
10.6.2009 |
8.6.2009 |
Abilify |
Otsuka Pharmaceutical Europe Ltd Hunton House
Highbridge Business Park
Oxford Road
Uxbridge
Middlesex
UB8 1HU
UNITED KINGDOM
|
EU/1/04/276/001-020 EU/1/04/276/024-036
|
10.6.2009 |
8.6.2009 |
Kivexa |
Glaxo Group Ltd Greenford
Middlesex
UB6 0NN
UNITED KINGDOM
|
EU/1/04/298/001-003 |
10.6.2009 |
9.6.2009 |
GONAL-f |
Serono Europe Limited 56 Marsh Wall
London
E14 9TP
UNITED KINGDOM
|
EU/1/95/001/001 EU/1/95/001/003-005
EU/1/95/001/009
EU/1/95/001/012
EU/1/95/001/021-022
EU/1/95/001/025-028
EU/1/95/001/031-035
|
11.6.2009 |
17.6.2009 |
Erbitux |
Merck KGaA Frankfurter Straße 250
64271 Darmstadt
DEUTSCHLAND
|
EU/1/04/281/001-005 |
19.6.2009 |
17.6.2009 |
Lucentis |
Novartis Europharm Limited Wimblehurst Road
Horsham
West Sussex
RH12 5AB
UNITED KINGDOM
|
EU/1/06/374/001 |
19.6.2009 |
18.6.2009 |
Vivanza |
Bayer Schering Pharma AG 13342 Berlin
DEUTSCHLAND
Bayer AG
51368 Leverkusen
DEUTSCHLAND
|
EU/1/03/249/001-012 |
22.6.2009 |
18.6.2009 |
Vasovist |
TMC Pharma Services Ltd Eversley
Hampshire
RG27 0NT
UNITED KINGDOM
Bayer Schering Pharma AG
13342 Berlin
DEUTSCHLAND
|
EU/1/05/313/001-009 |
22.6.2009 |
18.6.2009 |
Angiox |
The Medicines Company UK Ltd 115 L Milton Park
Abingdon
Oxfordshire
OX14 4SA
UNITED KINGDOM
|
EU/1/04/289/001-002 |
22.6.2009 |
18.6.2009 |
Emtriva |
Gilead Sciences International Limited Cambridge
CB21 6GT
UNITED KINGDOM
|
EU/1/03/261/001-002 |
22.6.2009 |
22.6.2009 |
Aclasta |
Novartis Europharm Limited Wimblehurst Road
Horsham
West Sussex
RH12 5AB
UNITED KINGDOM
|
EU/1/05/308/001-002 |
24.6.2009 |
22.6.2009 |
Yondelis |
Pharma Mar, S.A. Avda. de los Reyes, 1
Polígono Industrial La Mina
28770 Colmenar Viejo Madrid
ESPAÑA
|
EU/1/07/417/001-002 |
24.6.2009 |
22.6.2009 |
Levitra |
Bayer Schering Pharma AG 13342 Berlin
DEUTSCHLAND
Bayer AG
51368 Leverkusen
DEUTSCHLAND
|
EU/1/03/248/001-012 |
25.6.2009 |
23.6.2009 |
Ebixa |
H. Lundbeck A/S Ottiliavej 9
2500 Valby
DANMARK
|
EU/1/02/219/001-049 |
25.6.2009 |
23.6.2009 |
Prezista |
Janssen-Cilag International NV Turnhoutseweg 30
2340 Beerse
BELGIË
|
EU/1/06/380/004-005 |
25.6.2009 |
23.6.2009 |
Prezista |
Janssen-Cilag International NV Turnhoutseweg 30
2340 Beerse
BELGIË
|
EU/1/06/380/001-002 |
25.6.2009 |
23.6.2009 |
Yondelis |
Pharma Mar, S.A. Avda. de los Reyes, 1
Polígono Industrial La Mina
28770 Colmenar Viejo Madrid
ESPAÑA
|
EU/1/07/417/001-002 |
25.6.2009 |
23.6.2009 |
Aptivus |
Boehringer Ingelheim International GmbH Binger Straße 173
55216 Ingelheim am Rhein
DEUTSCHLAND
|
EU/1/05/315/002 |
25.6.2009 |
23.6.2009 |
Aptivus |
Boehringer Ingelheim International GmbH Binger Straße 173
55216 Ingelheim am Rhein
DEUTSCHLAND
|
EU/1/05/315/001 |
25.6.2009 |
24.6.2009 |
Ariclaim |
Eli Lilly Nederland B.V. Grootslag 1-5
3991 RA Houten
NEDERLAND
|
EU/1/04/283/008-012 |
26.6.2009 |
24.6.2009 |
YENTREVE |
Eli Lilly Nederland B.V. Grootslag 1-5
3991 RA Houten
NEDERLAND
|
EU/1/04/280/001-008 |
26.6.2009 |
24.6.2009 |
Xeristar |
Boehringer Ingelheim International GmbH Binger Straße 173
55216 Ingelheim am Rhein
DEUTSCHLAND
|
EU/1/04/297/001-008 |
29.6.2009 |
24.6.2009 |
Neupro |
Schwarz Pharma Ltd Shannon
Industrial Estate
Co.Clare
IRELAND
|
EU/1/05/331/001-055 |
26.6.2009 |
24.6.2009 |
Cymbalta |
Eli Lilly Nederland B.V. Grootslag 1-5
3991 RA Houten
NEDERLAND
|
EU/1/04/296/001-009 |
26.6.2009 |
24.6.2009 |
Axura |
Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104
60318 Frankfurt/Main
DEUTSCHLAND
|
EU/1/02/218/001-029 |
26.6.2009 |
29.6.2009 |
RotaTeq |
Sanofi Pasteur MSD, SNC 8 rue Jonas Salk
69007 Lyon
FRANCE
|
EU/1/06/348/001-002 |
2.7.2009 |
29.6.2009 |
Yttriga |
Nuclitec GmbH Gieselweg 1
38110 Braunschweig
DEUTSCHLAND
|
EU/1/05/322/001 |
1.7.2009 |
29.6.2009 |
Kepivance |
Biovitrum AB (publ) 112 76 Stockholm
SVERIGE
|
EU/1/05/314/001 |
2.7.2009 |
29.6.2009 |
Effentora |
Cephalon Europe 5 rue Charles Martigny
94700 Maisons-Alfort
FRANCE
|
EU/1/08/441/001-010 |
1.7.2009 |
30.6.2009 |
Cerezyme |
Genzyme Europe B.V. Gooimeer 10
1411 DD Naarden
NEDERLAND
|
EU/1/97/053/001-005 |
2.7.2009 |
30.6.2009 |
Hepsera |
Gilead Sciences International Limited Cambridge
CB21 6GT
UNITED KINGDOM
|
EU/1/03/251/001-002 |
2.7.2009 |
30.6.2009 |
Kineret |
Biovitrum AB (publ) 112 76 Stockholm
SVERIGE
|
EU/1/02/203/001-004 |
2.7.2009 |
30.6.2009 |
Ariclaim |
Eli Lilly Nederland B.V. Grootslag 1-5
3991 RA Houten
NEDERLAND
|
EU/1/04/283/008-012 |
2.7.2009 |
30.6.2009 |
BeneFIX |
Wyeth Europa Ltd. Huntercombe Lane South
Taplow
Maidenhead
Berkshire
SL6 0PH
UNITED KINGDOM
|
EU/1/97/047/001-007 |
2.7.2009 |