| Aflunov |
Human |
zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) |
influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23) |
EMEA/H/C/002094 |
Seqirus S.r.l. |
2010/11/28
|
Authorised |
| Leflunomide ratiopharm |
Human |
leflunomide |
leflunomide |
EMEA/H/C/002035 |
Ratiopharm GmbH |
2010/11/28
|
Authorised |
| BTVPUR AlSap 2-4 |
Veterinary |
inactivated adjuvanted vaccine against bluetongue virus serotype 2 and 4 infections |
bluetongue-virus serotype-2 antigen;bluetongue-virus serotype-4 antigen |
EMEA/V/C/000139 |
Mérial |
2010/11/04
|
Withdrawn |
| Ruconest |
Human |
conestat alfa |
recombinant human C1-inhibitor |
EMEA/H/C/001223 |
Pharming Group N.V. |
2010/10/28
|
Authorised |
| Clopidogrel HCS |
Human |
clopidogrel |
clopidogrel (as hydrochloride) |
EMEA/H/C/002255 |
HCS bvba |
2010/10/28
|
Authorised |
| Clopidogrel Teva Generics B.V. |
Human |
clopidogrel |
clopidogrel (as hydrochloride) |
EMEA/H/C/002254 |
Teva Pharma B.V. |
2010/10/28
|
Lapsed |
| Twynsta |
Human |
telmisartan;amlodipine |
telmisartan;amlodipine |
EMEA/H/C/001224 |
Boehringer Ingelheim International GmbH |
2010/10/07
|
Authorised |
| Myclausen |
Human |
mycophenolate mofetil |
mycophenolate mofetil |
EMEA/H/C/001218 |
Passauer Pharma GmbH |
2010/10/07
|
Authorised |
| Telmisartan Actavis |
Human |
telmisartan |
telmisartan |
EMEA/H/C/001168 |
Actavis Group PTC ehf |
2010/09/29
|
Authorised |
| Ibandronic Acid Teva |
Human |
ibandronic acid |
ibandronic acid |
EMEA/H/C/001195 |
Teva Pharma B.V. |
2010/09/17
|
Authorised |
| Rapiscan |
Human |
regadenoson |
regadenoson |
EMEA/H/C/001176 |
GE Healthcare AS |
2010/09/06
|
Authorised |
| 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Withdrawn |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 |