| Kalydeco |
Human |
ivacaftor |
ivacaftor |
EMEA/H/C/002494 |
Vertex Pharmaceuticals (Ireland) Limited |
2012/07/23
|
Authorised |
| Fycompa |
Human |
perampanel |
perampanel |
EMEA/H/C/002434 |
Eisai GmbH |
2012/07/23
|
Authorised |
| Eklira Genuair |
Human |
aclidinium bromide |
aclidinium bromide |
EMEA/H/C/002211 |
Covis Pharma Europe B.V. |
2012/07/20
|
Authorised |
| Bretaris Genuair |
Human |
aclidinium bromide |
aclidinium bromide |
EMEA/H/C/002706 |
Covis Pharma Europe B.V. |
2012/07/20
|
Authorised |
| Jentadueto |
Human |
linagliptin;metformin hydrochloride |
linagliptin;metformin |
EMEA/H/C/002279 |
Boehringer Ingelheim International GmbH |
2012/07/19
|
Authorised |
| Rienso |
Human |
ferumoxytol |
Ferumoxytol |
EMEA/H/C/002215 |
Takeda Pharma A/S |
2012/06/15
|
Withdrawn |
| Docetaxel Kabi |
Human |
docetaxel |
docetaxel |
EMEA/H/C/002325 |
Fresenius Kabi Deutschland GmbH |
2012/05/22
|
Authorised |
| Docetaxel Accord |
Human |
docetaxel |
docetaxel |
EMEA/H/C/002539 |
Accord Healthcare S.L.U. |
2012/05/22
|
Authorised |
| Pixuvri |
Human |
pixantrone dimaleate |
pixantrone dimaleate |
EMEA/H/C/002055 |
Les Laboratoires Servier |
2012/05/10
|
Expired |
| Riluzole Zentiva |
Human |
riluzole |
riluzole |
EMEA/H/C/002622 |
Zentiva k.s. |
2012/05/07
|
Authorised |
| Signifor |
Human |
pasireotide |
pasireotide |
EMEA/H/C/002052 |
Recordati Rare Diseases |
2012/04/24
|
Authorised |
| Capecitabine Teva |
Human |
capecitabine |
capecitabine |
EMEA/H/C/002362 |
Teva Pharma B.V. |
2012/04/20
|
Authorised |
| Ecansya (previously Capecitabine Krka) |
Human |
capecitabine |
capecitabine |
EMEA/H/C/002605 |
Krka, d.d., Novo mesto |
2012/04/20
|
Authorised |
| Capecitabine Accord |
Human |
capecitabine |
capecitabine |
EMEA/H/C/002386 |
Accord Healthcare S.L.U. |
2012/04/20
|
Authorised |
| Nimenrix |
Human |
meningococcal groups A, C, W-135 and Y conjugate vaccine |
Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid |
EMEA/H/C/002226 |
Pfizer Europe MA EEIG |
2012/04/20
|
Authorised |
| Sancuso |
Human |
granisetron |
granisetron |
EMEA/H/C/002296 |
Grünenthal GmbH |
2012/04/20
|
Authorised |
| Zoledronic acid Actavis |
Human |
zoledronic acid |
zoledronic acid monohydrate |
EMEA/H/C/002488 |
Actavis Group PTC ehf |
2012/04/20
|
Authorised |
| Bronchitol |
Human |
mannitol |
mannitol |
EMEA/H/C/001252 |
Pharmaxis Europe Limited |
2012/04/13
|
Authorised |
| Sabervel |
Human |
irbesartan |
irbesartan |
EMEA/H/C/002510 |
Pharmathen S.A. |
2012/04/13
|
Expired |
| Pioglitazone Teva |
Human |
pioglitazone |
pioglitazone hydrochloride |
EMEA/H/C/002297 |
Teva B.V. |
2012/03/26
|
Withdrawn |