| Lopinavir/Ritonavir Viatris (previously Ritonavir Mylan) |
Human |
lopinavir;ritonavir |
lopinavir;ritonavir |
EMEA/H/C/004025 |
Viatris Limited |
2016/01/14
|
Authorised |
| Oncaspar |
Human |
pegaspargase |
pegaspargase |
EMEA/H/C/003789 |
Les Laboratoires Servier |
2016/01/14
|
Authorised |
| Spectrila |
Human |
asparaginase |
asparaginase |
EMEA/H/C/002661 |
Medac Gesellschaft fuer klinische Spezialpraeparate mbH |
2016/01/14
|
Authorised |
| Episalvan |
Human |
birch bark extract |
Betulae cortex |
EMEA/H/C/003938 |
Amryt AG |
2016/01/14
|
Withdrawn |
| Briviact (in Italy: Nubriveo) |
Human |
brivaracetam |
Brivaracetam |
EMEA/H/C/003898 |
UCB Pharma SA |
2016/01/13
|
Authorised |
| Benepali |
Human |
etanercept |
etanercept |
EMEA/H/C/004007 |
Samsung Bioepis NL B.V. |
2016/01/13
|
Authorised |
| Eptifibatide Accord |
Human |
eptifibatide |
eptifibatide |
EMEA/H/C/004104 |
Accord Healthcare S.L.U. |
2016/01/11
|
Authorised |
| Imlygic |
Human |
talimogene laherparepvec |
talimogene laherparepvec |
EMEA/H/C/002771 |
Amgen Europe B.V. |
2015/12/16
|
Authorised |
| Velactis |
Veterinary |
cabergoline |
cabergoline |
EMEA/V/C/003739 |
Ceva Santé Animale |
2015/12/09
|
Withdrawn |
| 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Withdrawn |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Withdrawn |
| Genvoya |
Human |
elvitegravir;cobicistat;emtricitabine;tenofovir alafenamide |
elvitegravir;cobicistat;emtricitabine;tenofovir alafenamide |
EMEA/H/C/004042 |
Gilead Sciences Ireland UC |
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 |