| 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Withdrawn |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 |
| 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 |
| 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Withdrawn |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Withdrawn |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 |
| Edistride |
Human |
dapagliflozin |
dapagliflozin propanediol monohydrate |
EMEA/H/C/004161 |
AstraZeneca AB |
2015/11/09
|
Authorised |
| Cresemba |
Human |
isavuconazole |
isavuconazole |
EMEA/H/C/002734 |
Basilea Pharmaceutica Deutschland GmbH |
2015/10/15
|
Authorised |
| Praluent |
Human |
alirocumab |
alirocumab |
EMEA/H/C/003882 |
Sanofi Winthrop Industrie |
2015/09/23
|
Authorised |
| Fexeric |
Human |
ferric citrate coordination complex |
ferric citrate coordination complex |
EMEA/H/C/003776 |
Akebia Europe Limited |
2015/09/23
|
Lapsed |
| Zerbaxa |
Human |
ceftolozane;tazobactam |
ceftolozane sulfate;tazobactam sodium |
EMEA/H/C/003772 |
Merck Sharp & Dohme B.V. |
2015/09/18
|
Authorised |
| Pemetrexed Sandoz |
Human |
pemetrexed |
pemetrexed disodium hemipentahydrate |
EMEA/H/C/004011 |
Sandoz GmbH |
2015/09/18
|
Withdrawn |
| Zalviso |
Human |
sufentanil |
sufentanil |
EMEA/H/C/002784 |
FGK Representative Service GmbH |
2015/09/18
|
Withdrawn |