| Bovilis BTV8 |
Veterinary |
bluetongue virus serotype 8 |
bluetongue virus vaccine, serotype 8 (inactivated) |
EMEA/V/C/000148 |
Intervet International BV |
2010/09/06
|
Withdrawn |
| Brinavess |
Human |
vernakalant hydrochloride |
vernakalant hydrochloride |
EMEA/H/C/001215 |
Advanz Pharma Limited |
2010/09/01
|
Authorised |
| Sycrest |
Human |
asenapine |
asenapine maleate |
EMEA/H/C/001177 |
N.V. Organon |
2010/09/01
|
Authorised |
| PecFent |
Human |
fentanyl |
fentanyl |
EMEA/H/C/001164 |
Gruenenthal GmbH |
2010/08/31
|
Authorised |
| Vpriv |
Human |
velaglucerase alfa |
velaglucerase alfa |
EMEA/H/C/001249 |
Takeda Pharmaceuticals International AG Ireland Branch |
2010/08/26
|
Authorised |
| Leflunomide medac |
Human |
leflunomide |
leflunomide |
EMEA/H/C/001227 |
medac Gesellschaft für klinische Spezialpräparate mbH |
2010/07/27
|
Authorised |
| Ozurdex |
Human |
dexamethasone |
dexamethasone |
EMEA/H/C/001140 |
AbbVie Deutschland GmbH & Co. KG |
2010/07/26
|
Authorised |
| Daxas |
Human |
roflumilast |
roflumilast |
EMEA/H/C/001179 |
AstraZeneca AB |
2010/07/05
|
Authorised |
| Votrient |
Human |
pazopanib |
pazopanib |
EMEA/H/C/001141 |
Novartis Europharm Limited |
2010/06/14
|
Authorised |
| Olanzapine Apotex |
Human |
olanzapine |
olanzapine |
EMEA/H/C/001178 |
Apotex Europe BV |
2010/06/10
|
Withdrawn |
| Ribavirin Mylan (previously Ribavirin Three Rivers) |
Human |
ribavirin |
ribavirin |
EMEA/H/C/001185 |
Mylan S.A.S |
2010/06/10
|
Withdrawn |
| Topotecan Hospira |
Human |
topotecan |
topotecan |
EMEA/H/C/001192 |
Pfizer Europe MA EEIG |
2010/06/09
|
Authorised |
| Humenza |
Human |
pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) |
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs. |
EMEA/H/C/001202 |
Sanofi Pasteur S.A. |
2010/06/08
|
Withdrawn |
| Nivestim |
Human |
filgrastim |
filgrastim |
EMEA/H/C/001142 |
Pfizer Europe MA EEIG |
2010/06/07
|
Authorised |
| Tolura |
Human |
telmisartan |
telmisartan |
EMEA/H/C/001196 |
Krka, d.d., Novo mesto |
2010/06/04
|
Authorised |
| Prolia |
Human |
denosumab |
denosumab |
EMEA/H/C/001120 |
Amgen Europe B.V. |
2010/05/26
|
Authorised |
| Docefrez |
Human |
docetaxel |
docetaxel |
EMEA/H/C/001074 |
Sun Pharmaceutical Industries Europe B.V. |
2010/05/10
|
Withdrawn |
| Raloxifene Teva |
Human |
raloxifene |
raloxifene hydrochloride |
EMEA/H/C/001075 |
Teva B.V. |
2010/04/29
|
Authorised |
| Arzerra |
Human |
ofatumumab |
ofatumumab |
EMEA/H/C/001131 |
Novartis Europharm Ltd |
2010/04/19
|
Withdrawn |
| Ribavirin BioPartners |
Human |
ribavirin |
ribavirin |
EMEA/H/C/001184 |
BioPartners GmbH |
2010/04/06
|
Lapsed |