| Azacitidine Mylan |
Human |
azacitidine |
azacitidine |
EMEA/H/C/004984 |
Mylan Pharmaceuticals Limited |
2020/03/27
|
Authorised |
| Nubeqa |
Human |
darolutamide |
darolutamide |
EMEA/H/C/004790 |
Bayer AG |
2020/03/27
|
Authorised |
| Nustendi |
Human |
bempedoic acid;ezetimibe |
bempedoic acid;ezetimibe |
EMEA/H/C/004959 |
Daiichi Sankyo Europe GmbH |
2020/03/27
|
Authorised |
| Staquis |
Human |
crisaborole |
Crisaborole |
EMEA/H/C/004863 |
Pfizer Europe MA EEIG |
2020/03/27
|
Withdrawn |
| Lyumjev (previously Liumjev) |
Human |
insulin lispro |
insulin lispro |
EMEA/H/C/005037 |
Eli Lilly Nederland B.V. |
2020/03/24
|
Authorised |
| Azacitidine betapharm |
Human |
azacitidine |
azacitidine |
EMEA/H/C/005075 |
betapharm Arzneimittel GmbH |
2020/03/24
|
Authorised |
| Givlaari |
Human |
givosiran |
Givosiran |
EMEA/H/C/004775 |
Alnylam Netherlands B.V. |
2020/03/02
|
Authorised |
| Beovu |
Human |
brolucizumab |
brolucizumab |
EMEA/H/C/004913 |
Novartis Europharm Limited |
2020/02/13
|
Authorised |
| Recarbrio |
Human |
imipenem;cilastatin;relebactam |
imipenem monohydrate;cilastatin sodium;relebactam monohydrate |
EMEA/H/C/004808 |
Merck Sharp & Dohme B.V. |
2020/02/13
|
Authorised |
| Amsparity |
Human |
adalimumab |
adalimumab |
EMEA/H/C/004879 |
Pfizer Europe MA EEIG |
2020/02/13
|
Authorised |
| Azacitidine Accord |
Human |
azacitidine |
azacitidine |
EMEA/H/C/005147 |
Accord Healthcare S.L.U. |
2020/02/13
|
Authorised |
| Polivy |
Human |
polatuzumab vedotin |
polatuzumab vedotin |
EMEA/H/C/004870 |
Roche Registration GmbH |
2020/01/16
|
Authorised |
| Sunosi |
Human |
solriamfetol |
solriamfetol hydrochloride |
EMEA/H/C/004893 |
Atnahs Pharma Netherlands B.V. |
2020/01/16
|
Authorised |
| Mayzent |
Human |
siponimod |
siponimod fumaric acid |
EMEA/H/C/004712 |
Novartis Europharm Limited |
2020/01/13
|
Authorised |
| Deferasirox Accord |
Human |
deferasirox |
deferasirox |
EMEA/H/C/005156 |
Accord Healthcare S.L.U. |
2020/01/09
|
Authorised |
| Clopidogrel / Acetylsalicylic acid Viatris (previously Clopidogrel / Acetylsalicylic acid Mylan) |
Human |
clopidogrel;acetylsalicylic acid |
acetylsalicylic acid;clopidogrel hydrogen sulfate |
EMEA/H/C/004996 |
Mylan Pharmaceuticals Limited |
2020/01/09
|
Authorised |
| Isturisa |
Human |
osilodrostat |
osilodrostat phosphate |
EMEA/H/C/004821 |
Recordati Rare Diseases |
2020/01/09
|
Authorised |
| Tavlesse |
Human |
fostamatinib |
Fostamatinib disodium |
EMEA/H/C/005012 |
Instituto Grifols S.A. |
2020/01/09
|
Authorised |
| Cegfila (previously Pegfilgrastim Mundipharma) |
Human |
pegfilgrastim |
pegfilgrastim |
EMEA/H/C/005312 |
Mundipharma Corporation (Ireland) Limited |
2019/12/19
|
Authorised |
| Spravato |
Human |
esketamine |
esketamine hydrochloride |
EMEA/H/C/004535 |
Janssen-Cilag International NV |
2019/12/18
|
Authorised |