| Poteligeo |
Human |
mogamulizumab |
mogamulizumab |
EMEA/H/C/004232 |
Kyowa Kirin Holdings B.V. |
2018/11/22
|
Authorised |
| Alunbrig |
Human |
brigatinib |
brigatinib |
EMEA/H/C/004248 |
Takeda Pharma A/S |
2018/11/22
|
Authorised |
| Ziextenzo |
Human |
pegfilgrastim |
pegfilgrastim |
EMEA/H/C/004802 |
Sandoz GmbH |
2018/11/22
|
Authorised |
| Vaborem |
Human |
meropenem;vaborbactam |
meropenem trihydrate;vaborbactam |
EMEA/H/C/004669 |
Menarini International Operations Luxembourg S.A. |
2018/11/20
|
Authorised |
| Pelmeg |
Human |
pegfilgrastim |
pegfilgrastim |
EMEA/H/C/004700 |
Mundipharma Corporation (Ireland) Limited |
2018/11/20
|
Authorised |
| Buvidal |
Human |
buprenorphine |
buprenorphine |
EMEA/H/C/004651 |
Camurus AB |
2018/11/20
|
Authorised |
| Apealea |
Human |
paclitaxel |
paclitaxel |
EMEA/H/C/004154 |
Inceptua AB |
2018/11/20
|
Withdrawn |
| Fulphila |
Human |
pegfilgrastim |
pegfilgrastim |
EMEA/H/C/004915 |
Biosimilar Collaborations Ireland Limited |
2018/11/20
|
Authorised |
| Emgality |
Human |
galcanezumab |
Galcanezumab |
EMEA/H/C/004648 |
Eli Lilly Nederland B.V. |
2018/11/14
|
Authorised |
| Symkevi |
Human |
tezacaftor;ivacaftor |
tezacaftor;ivacaftor |
EMEA/H/C/004682 |
Vertex Pharmaceuticals (Ireland) Limited |
2018/10/31
|
Authorised |
| Gefitinib Mylan |
Human |
gefitinib |
gefitinib |
EMEA/H/C/004826 |
Mylan Pharmaceuticals Limited |
2018/09/27
|
Withdrawn |
| Verzenios |
Human |
abemaciclib |
abemaciclib |
EMEA/H/C/004302 |
Eli Lilly Nederland B.V. |
2018/09/26
|
Authorised |
| Imfinzi |
Human |
durvalumab |
durvalumab |
EMEA/H/C/004771 |
AstraZeneca AB |
2018/09/21
|
Authorised |
| Pelgraz |
Human |
pegfilgrastim |
pegfilgrastim |
EMEA/H/C/003961 |
Accord Healthcare S.L.U. |
2018/09/21
|
Authorised |
| Udenyca |
Human |
pegfilgrastim |
pegfilgrastim |
EMEA/H/C/004413 |
ERA Consulting GmbH |
2018/09/21
|
Withdrawn |
| Slenyto |
Human |
melatonin |
melatonin |
EMEA/H/C/004425 |
RAD Neurim Pharmaceuticals EEC SARL |
2018/09/20
|
Authorised |
| Mektovi |
Human |
binimetinib |
binimetinib |
EMEA/H/C/004579 |
Pierre Fabre Medicament |
2018/09/20
|
Authorised |
| Kigabeq |
Human |
vigabatrin |
vigabatrin |
EMEA/H/C/004534 |
ORPHELIA Pharma |
2018/09/20
|
Authorised |
| Xerava |
Human |
eravacycline |
eravacycline |
EMEA/H/C/004237 |
PAION Pharma GmbH |
2018/09/20
|
Authorised |
| Lenalidomide Accord |
Human |
lenalidomide |
lenalidomide |
EMEA/H/C/004857 |
Accord Healthcare S.L.U. |
2018/09/20
|
Authorised |