| Opgenra |
Human |
eptotermin alfa |
eptotermin alfa |
EMEA/H/C/000819 |
Olympus Biotech International Limited |
2009/02/19
|
Withdrawn |
| Firmagon |
Human |
degarelix |
degarelix |
EMEA/H/C/000986 |
Ferring Pharmaceuticals A/S |
2009/02/17
|
Authorised |
| Filgrastim Hexal |
Human |
filgrastim |
filgrastim |
EMEA/H/C/000918 |
Hexal AG |
2009/02/06
|
Authorised |
| Zarzio |
Human |
filgrastim |
filgrastim |
EMEA/H/C/000917 |
Sandoz GmbH |
2009/02/06
|
Authorised |
| Nplate |
Human |
romiplostim |
romiplostim |
EMEA/H/C/000942 |
Amgen Europe B.V. |
2009/02/04
|
Authorised |
| RoActemra |
Human |
tocilizumab |
tocilizumab |
EMEA/H/C/000955 |
Roche Registration GmbH |
2009/01/16
|
Authorised |
| Rasilez HCT |
Human |
aliskiren;hydrochlorothiazide |
aliskiren;hydrochlorothiazide |
EMEA/H/C/000964 |
Noden Pharma DAC |
2009/01/16
|
Withdrawn |
| Stelara |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/000958 |
Janssen-Cilag International NV |
2009/01/15
|
Authorised |
| Pramipexole Teva |
Human |
pramipexole |
pramipexole dihydrochloride monohydrate |
EMEA/H/C/000940 |
Teva Pharma B.V. |
2008/12/18
|
Authorised |
| Vidaza |
Human |
azacitidine |
azacitidine |
EMEA/H/C/000978 |
Bristol-Myers Squibb Pharma EEIG |
2008/12/17
|
Authorised |
| Acticam |
Veterinary |
meloxicam |
meloxicam |
EMEA/V/C/000138 |
Ecuphar |
2008/12/09
|
Withdrawn |
| Kuvan |
Human |
sapropterin |
sapropterin dihydrochloride |
EMEA/H/C/000943 |
BioMarin International Limited |
2008/12/02
|
Authorised |
| Ifirmasta (previously Irbesartan Krka) |
Human |
irbesartan |
irbesartan hydrochloride |
EMEA/H/C/000962 |
Krka, d.d., Novo mesto |
2008/12/01
|
Authorised |
| Icandra (previously Vildagliptin / metformin hydrochloride Novartis) |
Human |
vildagliptin;metformin |
vildagliptin;metformin hydrochloride |
EMEA/H/C/001050 |
Novartis Europharm Limited |
2008/11/30
|
Authorised |
| Zomarist |
Human |
vildagliptin;metformin |
vildagliptin;metformin hydrochloride |
EMEA/H/C/001049 |
Novartis Europharm Limited |
2008/11/30
|
Authorised |
| Azarga |
Human |
brinzolamide;timolol |
brinzolamide;timolol maleate |
EMEA/H/C/000960 |
Novartis Europharm Limited |
2008/11/25
|
Authorised |
| Zypadhera |
Human |
olanzapine |
olanzapine pamoate |
EMEA/H/C/000890 |
CHEPLAPHARM Registration GmbH |
2008/11/19
|
Authorised |
| Jalra |
Human |
vildagliptin |
vildagliptin |
EMEA/H/C/001048 |
Novartis Europharm Limited |
2008/11/19
|
Authorised |
| Xiliarx |
Human |
vildagliptin |
vildagliptin |
EMEA/H/C/001051 |
Novartis Europharm Limited |
2008/11/19
|
Authorised |
| Duloxetine Boehringer Ingelheim |
Human |
duloxetine |
duloxetine |
EMEA/H/C/001007 |
Boehringer Ingelheim International GmbH |
2008/10/08
|
Withdrawn |