| Sebivo |
Human |
telbivudine |
telbivudine |
EMEA/H/C/000713 |
Novartis Europharm Limited |
2007/04/24
|
Withdrawn |
| Advagraf |
Human |
tacrolimus |
tacrolimus |
EMEA/H/C/000712 |
Astellas Pharma Europe BV |
2007/04/23
|
Authorised |
| Toviaz |
Human |
fesoterodine |
fesoterodine fumarate |
EMEA/H/C/000723 |
Pfizer Europe MA EEIG |
2007/04/20
|
Authorised |
| Docetaxel Zentiva (previously Docetaxel Winthrop) |
Human |
docetaxel |
docetaxel |
EMEA/H/C/000808 |
Zentiva k.s. |
2007/04/20
|
Withdrawn |
| Slentrol |
Veterinary |
dirlotapide |
dirlotapide |
EMEA/V/C/000116 |
Zoetis Belgium SA |
2007/04/13
|
Withdrawn |
| Xelevia |
Human |
sitagliptin |
sitagliptin |
EMEA/H/C/000762 |
Merck Sharp & Dohme B.V. |
2007/03/21
|
Authorised |
| Daronrix |
Human |
pandemic influenza vaccine (whole virion, inactivated, adjuvanted) |
whole virion, inactivated, containing antigen*: A/Vietnam/1194/2004 (H5N1)* produced in eggs |
EMEA/H/C/000706 |
GlaxoSmithKline Biologicals S.A. |
2007/03/21
|
Lapsed |
| Januvia |
Human |
sitagliptin |
sitagliptin |
EMEA/H/C/000722 |
Merck Sharp and Dohme B.V |
2007/03/20
|
Authorised |
| Cystadane |
Human |
betaine anhydrous |
Betaine anhydrous |
EMEA/H/C/000678 |
Recordati Rare Diseases |
2007/02/14
|
Authorised |
| Prezista |
Human |
darunavir |
darunavir |
EMEA/H/C/000707 |
Janssen-Cilag International NV |
2007/02/11
|
Authorised |
| Lucentis |
Human |
ranibizumab |
ranibizumab |
EMEA/H/C/000715 |
Novartis Europharm Limited |
2007/01/22
|
Authorised |
| Irbesartan Zentiva (previously Irbesartan Winthrop) |
Human |
irbesartan |
irbesartan |
EMEA/H/C/000785 |
Zentiva k.s. |
2007/01/19
|
Authorised |
| Irbesartan BMS |
Human |
irbesartan |
irbesartan |
EMEA/H/C/000786 |
Bristol-Myers Squibb Pharma EEIG |
2007/01/19
|
Withdrawn |
| Irbesartan Hydrochlorothiazide BMS |
Human |
irbesartan;hydrochlorothiazide |
irbesartan;hydrochlorothiazide |
EMEA/H/C/000784 |
Bristol-Myers Squibb Pharma EEIG |
2007/01/19
|
Withdrawn |
| Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop) |
Human |
irbesartan;hydrochlorothiazide |
irbesartan;hydrochlorothiazide |
EMEA/H/C/000783 |
sanofi-aventis groupe |
2007/01/18
|
Authorised |
| Insulin Human Winthrop |
Human |
insulin human |
Insulin human |
EMEA/H/C/000761 |
sanofi-aventis Deutschland GmbH |
2007/01/17
|
Withdrawn |
| Imprida |
Human |
amlodipine;valsartan |
valsartan;amlodipine (as amlodipine besilate) |
EMEA/H/C/000775 |
Novartis Europharm Ltd |
2007/01/17
|
Withdrawn |
| Exforge |
Human |
amlodipine;valsartan |
valsartan;amlodipine (as amlodipine besilate) |
EMEA/H/C/000716 |
Novartis Europharm Limited |
2007/01/16
|
Authorised |
| Inovelon |
Human |
rufinamide |
rufinamide |
EMEA/H/C/000660 |
Eisai GmbH |
2007/01/16
|
Authorised |
| Dafiro |
Human |
amlodipine;valsartan |
amlodipine;valsartan |
EMEA/H/C/000776 |
Novartis Europharm Limited |
2007/01/15
|
Authorised |