Data wydania decyzji |
Nazwa produktu leczniczego |
Posiadacz pozwolenia na dopuszczenie do obrotu |
Numer wpisu w rejestrze wspólnotowym |
Data notyfikacji |
2.3.2009 |
Fendrix |
GlaxoSmithKline Biologicals s.a. rue de l'Institut 89
Rixensart, B-1330
BELGIQUE
|
EU/1/04/299/001-003 |
4.3.2009 |
2.3.2009 |
Cymbalta |
Eli Lilly Nederland B.V. Grootslag 1-5
3991 RA Houten
NEDERLAND
|
EU/1/04/296/001-009 |
4.3.2009 |
2.3.2009 |
Fareston |
Orion Corporation Orionintie 1
FIN-02200 Espoo
SUOMI
|
EU/1/96/004/001-002 |
4.3.2009 |
2.3.2009 |
Nexavar |
Bayer HealthCare AG D-51368 Leverkusen
DEUTSCHLAND
|
EU/1/06/342/001 |
4.3.2009 |
2.3.2009 |
Irbesartan BMS |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road
Uxbridge UB8 1DH
UNITED KINGDOM
|
EU/1/06/375/001-033 |
4.3.2009 |
2.3.2009 |
Aptivus |
Boehringer Ingelheim International GmbH Binger Strasse 173
D-55216 Ingelheim am Rhein
DEUTSCHLAND
|
EU/1/05/315/001 |
4.3.2009 |
2.3.2009 |
Ganfort |
Allergan Pharmaceuticals Ireland Castlebar Road
Westport, Co. Mayo
IRELAND
|
EU/1/06/340/001-002 |
5.3.2009 |
4.3.2009 |
KOGENATE Bayer |
Bayer HealthCare AG 51368 Leverkusen
DEUTSCHLAND
|
EU/1/00/143/001-011 |
6.3.2009 |
4.3.2009 |
Helixate NexGen |
Bayer HealthCare AG 51368 Leverkusen
DEUTSCHLAND
|
EU/1/00/144/001-004 |
6.3.2009 |
4.3.2009 |
Gardasil |
Sanofi Pasteur MSD SNC, 8, rue Jonas Salk
69007 Lyon
FRANCE
|
EU/1/06/357/001-021 |
6.3.2009 |
4.3.2009 |
Cystadane |
Orphan Europe S.a.r.l. Immeuble Le Wilson
70 Avenue du Général de Gaulle
92800 Puteaux
FRANCE
|
EU/1/06/379/001 |
6.3.2009 |
4.3.2009 |
Photobarr |
Axcan Pharma International BV Engelenkampstraat 72
6131 JJ Sittard
NEDERLAND
|
EU/1/04/272/001-002 |
6.3.2009 |
6.3.2009 |
Silgard |
Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon
Hertfordshire EN11 9BU
UNITED KINGDOM
|
EU/1/06/358/001-021 |
10.3.2009 |
6.3.2009 |
BYETTA |
Eli Lilly Nederland B.V. Grootslag 1-5
3991 RA Houten
NEDERLAND
|
EU/1/06/362/001-004 |
10.3.2009 |
6.3.2009 |
IntronA |
Schering Plough Europe Rue de Stalle, 73
1180 Bruxelles
BELGIQUE
|
EU/1/99/127/001-044 |
10.3.2009 |
6.3.2009 |
Remicade |
Centocor B.V. Einsteinweg 101
2333 CB Leiden
NEDERLAND
|
EU/1/99/116/001-005 |
10.3.2009 |
6.3.2009 |
Protelos |
Les Laboratoires Servier 22, rue Garnier
92200 Neuilly-sur-Seine
FRANCE
|
EU/1/04/288/001-006 |
10.3.2009 |
6.3.2009 |
ATryn |
LEO Pharma A/S Industriparken 55
DK-2750 Ballerup
DANMARK
|
EU/1/06/355/001-003 |
10.3.2009 |
6.3.2009 |
Irbesartan Hydrochloro-thiazide Winthrop |
SANOFI PHARMA BRISTOL MYERS SQUIBB SNC
174 avenue de France
F-75013 Paris
FRANCE
|
EU/1/06/377/001-028 |
10.3.2009 |
9.3.2009 |
Optisulin |
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main
DEUTSCHLAND
|
EU/1/00/133/001-032 |
11.3.2009 |
9.3.2009 |
Osseor |
Les Laboratoires Servier 22, rue Garnier
92200 Neuilly-sur-Seine
FRANCE
|
EU/1/04/287/001-006 |
11.3.2009 |
9.3.2009 |
Sustiva |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road
Uxbridge UB8 1DH
UNITED KINGDOM
|
EU/1/99/110/001-009 |
11.3.2009 |
10.3.2009 |
DULOXETINE BOEHRINGER INGELHEIM |
Boehringer Ingelheim International GmbH Binger Strasse 173
D-55216 Ingelheim am Rhein
DEUTSCHLAND
|
EU/1/08/471/001-012 |
12.3.2009 |
17.3.2009 |
Pritor Plus |
Bayer HealthCare AG 51368 Leverkusen
DEUTSCHLAND
|
EU/1/02/215/001-021 |
19.3.2009 |
17.3.2009 |
Irbesartan Winthrop |
SANOFI PHARMA BRISTOL MYERS SQUIBB SNC
174 avenue de France
F-75013 Paris
FRANCE
|
EU/1/06/376/001-033 |
19.3.2009 |
17.3.2009 |
Pritor |
Bayer HealthCare AG 51368 Leverkusen
DEUTSCHLAND
|
EU/1/98/089/001-022 |
19.3.2009 |
17.3.2009 |
Hycamtin |
SmithKline Beecham plc 980 Great West Road, Brentford
Middlesex, TW8 9GS
UNITED KINGDOM
|
EU/1/96/027/001 EU/1/96/027/003-007 |
19.3.2009 |
17.3.2009 |
Onsenal |
Pfizer Limited Ramsgate Road, Sandwich
Kent CT13 9NJ
UNITED KINGDOM
|
EU/1/03/259/001-006 |
19.3.2009 |
18.3.2009 |
Irbesartan HCT BMS |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road
Uxbridge UB8 1DH
UNITED KINGDOM
|
EU/1/06/369/001-028 |
20.3.2009 |
18.3.2009 |
Atriance |
Glaxo Group Limited Berkeley Avenue, Greenford
Middlesex UB6 0NN
UNITED KINGDOM
|
EU/1/07/403/001 |
20.3.2009 |
18.3.2009 |
Kinzalkomb |
Bayer HealthCare AG 51368 Leverkusen
DEUTSCHLAND
|
EU/1/02/214/001-015 |
20.3.2009 |
18.3.2009 |
MicardisPlus |
Boehringer Ingelheim International GmbH Binger Strasse 173
D-55216 Ingelheim am Rhein
DEUTSCHLAND
|
EU/1/02/213/001-023 |
20.3.2009 |
18.3.2009 |
Kinzalmono |
Bayer HealthCare AG 51368 Leverkusen
DEUTSCHLAND
|
EU/1/98/091/001-014 |
20.3.2009 |
19.3.2009 |
Regranex |
Janssen-Cilag International NV Turnhoutseweg
30-2340 Beerse -
BELGIË
|
EU/1/99/101/001 |
23.3.2009 |
19.3.2009 |
Stalevo |
Orion Corporation Orionintie 1
FIN-02200 Espoo
SUOMI
|
EU/1/03/260/001-023 |
23.3.2009 |
19.3.2009 |
Micardis |
Boehringer Ingelheim International GmbH Binger Strasse 173
D-55216 Ingelheim am Rhein
DEUTSCHLAND
|
EU/1/98/090/001-020 |
23.3.2009 |
19.3.2009 |
Vectibix |
Amgen Europe B.V. Minervum 7061
NL-4817 ZK Breda
NEDERLAND
|
EU/1/07/423/001-003 |
23.3.2009 |
23.3.2009 |
NovoSeven |
Novo Nordisk A/S Novo Allé
DK-2880 Bagsvaerd
DANMARK
|
EU/1/96/006/001-003 |
25.3.2009 |
23.3.2009 |
Irbesartan BMS |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road
Uxbridge UB8 1DH
UNITED KINGDOM
|
EU/1/06/375/001-033 |
25.3.2009 |
25.3.2009 |
Avastin |
Roche Registration Limited 6 Falcon Way, Shire Park
Welwyn Garden City, AL7 1TW
UNITED KINGDOM
|
EU/1/04/300/001-002 |
27.3.2009 |
25.3.2009 |
Enbrel |
Wyeth Europa Limited Huntercombe Lane South, Taplow
Maidenhead, Berkshire, SL6 0PH
UNITED KINGDOM
|
EU/1/99/126/001-018 |
27.3.2009 |
25.3.2009 |
Telzir |
Glaxo Group Ltd. Greenford Road, Greenford
Middlesex UB6 0NN
UNITED KINGDOM
|
EU/1/04/282/001-002 |
27.3.2009 |
25.3.2009 |
Ariclaim |
Eli Lilly Nederland B.V. Grootslag 1-5
3991 RA Houten
NEDERLAND
|
EU/1/04/283/001-012 |
27.3.2009 |
25.3.2009 |
Exjade |
Novartis Europharm Limited Wimblehurst Road, Horsham
West Sussex RH12 5AB
UNITED KINGDOM
|
EU/1/06/356/001-009 |
27.3.2009 |
25.3.2009 |
Arixtra |
Glaxo Group Ltd. Greenford Road, Greenford
Middlesex UB6 0NN
UNITED KINGDOM
|
EU/1/02/206/001-035 |
27.3.2009 |
25.3.2009 |
Xenical |
Roche Registration Limited 6 Falcon Way, Shire Park
Welwyn Garden City, AL7 1TW
UNITED KINGDOM
|
EU/1/98/071/001-006 |
27.3.2009 |
25.3.2009 |
Cymbalta |
Eli Lilly Nederland B.V. Grootslag 1-5
3991 RA Houten
NEDERLAND
|
EU/1/04/296/001-009 |
27.3.2009 |
25.3.2009 |
Advagraf |
Astellas Pharma Europe B.V. Elisabethhof 19
NL-2353 EW Leiderdorp
NEDERLAND
|
EU/1/07/387/001-010 |
27.3.2009 |
25.3.2009 |
Pradaxa |
Boehringer Ingelheim International GmbH Binger Strasse 173
D-55216 Ingelheim am Rhein
DEUTSCHLAND
|
EU/1/08/442/001-008 |
27.3.2009 |
25.3.2009 |
Zyprexa |
Eli Lilly Nederland B.V. 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/1/96/022/016-017
EU/1/96/022/019-034
|
27.3.2009 |
25.3.2009 |
ProQuad |
Sanofi Pasteur MSD SNC, 8, rue Jonas Salk
69007 Lyon
FRANCE
|
EU/1/05/323/001-013 |
27.3.2009 |
25.3.2009 |
Cetrotide |
Serono Europe Limited 56, Marsh Wall
London E14 9TP
UNITED KINGDOM
|
EU/1/99/100/001-003 |
27.3.2009 |
25.3.2009 |
Tyverb |
Glaxo Group Limited Berkeley Avenue, Greenford
Middlesex UB6 0NN
UNITED KINGDOM
|
EU/1/07/440/001-002 |
27.3.2009 |
25.3.2009 |
Lysodren |
Laboratoire HRA Pharma 15, rue Béranger
75003 Paris
FRANCE
|
EU/1/04/273/001 |
27.3.2009 |
25.3.2009 |
Zyprexa Velotab |
Eli Lilly Nederland B.V. Grootslag 1-5
3991 RA Houten
NEDERLAND
|
EU/1/99/125/001-016 |
27.3.2009 |
25.3.2009 |
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 |
27.3.2009 |
25.3.2009 |
Extavia |
Novartis Europharm Limited Wimblehurst Road, Horsham
West Sussex RH12 5AB
UNITED KINGDOM
|
EU/1/08/454/001-002 EU/1/08/454/005 |
27.3.2009 |
25.3.2009 |
Mabthera |
Roche Registration Limited 6 Falcon Way, Shire Park
Welwyn Garden City, AL7 1TW
UNITED KINGDOM
|
EU/1/98/067/001-002 |
27.3.2009 |
25.3.2009 |
Beromun |
Boehringer Ingelheim International GmbH Binger Strasse 173
D-55216 Ingelheim am Rhein
DEUTSCHLAND
|
EU/1/99/097/001 |
27.3.2009 |
25.3.2009 |
Dukoral |
SBL Vaccin AB S-105 21 Stockholm
SWEDEN
|
EU/1/03/263/001-003 |
30.3.2009 |
25.3.2009 |
NeuroBloc |
Eisai Limited 3, Shortlands
London W6 8EE
UNITED KINGDOM
|
EU/1/00/166/001-003 |
30.3.2009 |
25.3.2009 |
Xeristar |
Boehringer Ingelheim International GmbH Binger Strasse 173
D-55216 Ingelheim am Rhein
DEUTSCHLAND
|
EU/1/04/297/001-008 |
27.3.2009 |
27.3.2009 |
Aerinaze |
SP Europe Rue de Stalle, 73, 1180 Bruxelles, BELGIQUE -
Stallestraat, 73 - 1180 Brussel
BELGIË
|
EU/1/07/399/001-006 |
1.4.2009 |
27.3.2009 |
Liprolog |
Eli Lilly Nederland B.V. Grootslag 1-5
3991 RA Houten
NEDERLAND
|
EU/1/01/195/001-015 EU/1/01/195/022-025 |
1.4.2009 |
27.3.2009 |
Karvezide |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road
Uxbridge UB8 1DH
UNITED KINGDOM
|
EU/1/98/085/001-034 |
1.4.2009 |
27.3.2009 |
Irbesartan HCT Winthrop |
SANOFI PHARMA BRISTOL MYERS SQUIBB SNC
174 avenue de France
F-75013 Paris
FRANCE
|
EU/1/06/377/001-028 |
1.4.2009 |
27.3.2009 |
Litak |
Lipomed GmbH Schönaugasse 11 D-79713 Bad Säckingen
DEUTSCHLAND
|
EU/1/04/275/001-002 |
1.4.2009 |
27.3.2009 |
Procoralan |
Les Laboratoires Servier 22, rue Garnier
92200 Neuilly-sur-Seine
FRANCE
|
EU/1/05/316/001-014 |
1.4.2009 |
27.3.2009 |
Mimpara |
Amgen Europe B.V. Minervum 7061
NL-4817 ZK Breda
NEDERLAND
|
EU/1/04/292/001-012 |
1.4.2009 |
27.3.2009 |
TRIZIVIR |
Glaxo Group Ltd. Greenford Road, Greenford
Middlesex UB6 0NN
UNITED KINGDOM
|
EU/1/00/156/002-003 |
1.4.2009 |
27.3.2009 |
Dafiro |
Novartis Europharm Limited Wimblehurst Road, Horsham
West Sussex RH12 5AB
UNITED KINGDOM
|
EU/1/06/371/001-036 |
1.4.2009 |
27.3.2009 |
Copalia |
Novartis Europharm Limited Wimblehurst Road, Horsham
West Sussex RH12 5AB
UNITED KINGDOM
|
EU/1/06/372/001-036 |
1.4.2009 |
27.3.2009 |
Imprida |
Novartis Europharm Limited Wimblehurst Road, Horsham
West Sussex RH12 5AB
UNITED KINGDOM
|
EU/1/06/373/001-036 |
1.4.2009 |
27.3.2009 |
Exforge |
Novartis Europharm Limited Wimblehurst Road, Horsham
West Sussex RH12 5AB
UNITED KINGDOM
|
EU/1/06/370/001-036 |
1.4.2009 |
27.3.2009 |
Stalevo |
Orion Corporation Orionintie 1
FIN-02200 Espoo
SUOMI
|
EU/1/03/260/024-033 |
1.4.2009 |
30.3.2009 |
Cholestagel |
Genzyme Europe B.V. Gooimeer 10
NL-1411 DD Naarden
NEDERLAND
|
EU/1/03/268/001-004 |
1.4.2009 |
31.3.2009 |
Rapilysin |
Actavis Group PTC ehf. Reykjavikurvegi 76-78
220 Hafnarfjordur
ICELAND
|
EU/1/96/018/001 |
2.4.2009 |
31.3.2009 |
Velcade |
Janssen-Cilag International NV Turnhoutseweg 30
B-2340 Beerse
BELGIË
|
EU/1/04/274/001-002 |
2.4.2009 |
31.3.2009 |
Aprovel |
Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France -
75013 Paris
FRANCE
|
EU/1/97/046/001-039 |
2.4.2009 |
31.3.2009 |
Karvea |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road
Uxbridge UB8 1DH
UNITED KINGDOM
|
EU/1/97/049/001-039 |
2.4.2009 |
31.3.2009 |
CoAprovel |
Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France -
75013 Paris
FRANCE
|
EU/1/98/086/001-034 |
2.4.2009 |