| Ciambra |
Human |
pemetrexed |
pemetrexed disodium hemipentahydrate |
EMEA/H/C/003788 |
Menarini International Operations Luxembourg S.A. |
2015/12/02
|
Withdrawn |
| Nucala |
Human |
mepolizumab |
Mepolizumab |
EMEA/H/C/003860 |
GlaxoSmithKline Trading Services Limited |
2015/12/01
|
Authorised |
| Ravicti |
Human |
glycerol phenylbutyrate |
glycerol phenylbutyrate |
EMEA/H/C/003822 |
Immedica Pharma AB |
2015/11/26
|
Authorised |
| Pemetrexed medac |
Human |
pemetrexed |
pemetrexed |
EMEA/H/C/003905 |
medac Gesellschaft für klinische Spezialpräparate mbH |
2015/11/26
|
Authorised |
| Blincyto |
Human |
blinatumomab |
blinatumomab |
EMEA/H/C/003731 |
Amgen Europe B.V. |
2015/11/23
|
Authorised |
| Cotellic |
Human |
cobimetinib |
cobimetinib hemifumarate |
EMEA/H/C/003960 |
Roche Registration GmbH |
2015/11/20
|
Authorised |
| Praxbind |
Human |
idarucizumab |
idarucizumab |
EMEA/H/C/003986 |
Boehringer Ingelheim International GmbH |
2015/11/20
|
Authorised |
| Kolbam |
Human |
cholic acid |
cholic acid |
EMEA/H/C/002081 |
Retrophin Europe Ltd |
2015/11/20
|
Withdrawn |
| Kyprolis |
Human |
carfilzomib |
carfilzomib |
EMEA/H/C/003790 |
Amgen Europe B.V. |
2015/11/19
|
Authorised |
| Orkambi |
Human |
lumacaftor;ivacaftor |
Lumacaftor;ivacaftor |
EMEA/H/C/003954 |
Vertex Pharmaceuticals (Ireland) Limited |
2015/11/19
|
Authorised |
| Cinacalcet Viatris (previously Cinacalcet Mylan) |
Human |
cinacalcet |
cinacalcet hydrochloride |
EMEA/H/C/004014 |
Mylan Pharmaceuticals Limited |
2015/11/19
|
Authorised |
| Pemetrexed Pfizer (previously Pemetrexed Hospira) |
Human |
pemetrexed |
pemetrexed disodium;pemetrexed disodium hemipentahydrate |
EMEA/H/C/003970 |
Pfizer Europe MA EEIG |
2015/11/19
|
Authorised |
| Entresto |
Human |
sacubitril;valsartan |
sacubitril;valsartan |
EMEA/H/C/004062 |
Novartis Europharm Limited |
2015/11/19
|
Authorised |
| Genvoya |
Human |
elvitegravir;cobicistat;emtricitabine;tenofovir alafenamide |
elvitegravir;cobicistat;emtricitabine;tenofovir alafenamide |
EMEA/H/C/004042 |
Gilead Sciences Ireland UC |
2015/11/19
|
Authorised |
| Numient |
Human |
levodopa;carbidopa |
levodopa;carbidopa |
EMEA/H/C/002611 |
Amneal Pharma Europe Ltd |
2015/11/19
|
Withdrawn |
| Elocta |
Human |
efmoroctocog alfa |
efmoroctocog alfa |
EMEA/H/C/003964 |
Swedish Orphan Biovitrum AB (publ) |
2015/11/18
|
Authorised |
| Ionsys |
Human |
fentanyl |
fentanyl hydrochloride |
EMEA/H/C/002715 |
Incline Therapeutics Europe Ltd |
2015/11/18
|
Withdrawn |
| Ebymect |
Human |
dapagliflozin;metformin |
dapagliflozin propanediol monohydrate;metformin hydrochloride |
EMEA/H/C/004162 |
AstraZeneca AB |
2015/11/15
|
Authorised |
| Aripiprazole Accord |
Human |
aripiprazole |
aripiprazole |
EMEA/H/C/004021 |
Accord Healthcare S.L.U. |
2015/11/15
|
Authorised |
| Obizur |
Human |
susoctocog alfa |
susoctocog alfa |
EMEA/H/C/002792 |
Baxalta Innovations GmbH |
2015/11/11
|
Authorised |