| 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 |
| Rinvoq |
Human |
upadacitinib |
upadacitinib |
EMEA/H/C/004760 |
AbbVie Deutschland GmbH & Co. KG |
2019/12/16
|
Authorised |
| Baqsimi |
Human |
glucagon |
Glucagon |
EMEA/H/C/003848 |
Amphastar France Pharmaceuticals |
2019/12/16
|
Authorised |
| Quofenix |
Human |
delafloxacin |
delafloxacin meglumine |
EMEA/H/C/004860 |
A. Menarini Industrie Farmaceutiche Riunite s.r.l. |
2019/12/16
|
Authorised |
| Evenity |
Human |
romosozumab |
romosozumab |
EMEA/H/C/004465 |
UCB Pharma S.A. |
2019/12/09
|
Authorised |
| Rhokiinsa |
Human |
netarsudil |
netarsudil |
EMEA/H/C/004583 |
Santen Oy |
2019/11/19
|
Authorised |
| Bortezomib Fresenius Kabi |
Human |
bortezomib |
bortezomib |
EMEA/H/C/005074 |
Fresenius Kabi Deutschland GmbH |
2019/11/14
|
Authorised |
| Arsenic trioxide Accord |
Human |
arsenic trioxide |
arsenic trioxide |
EMEA/H/C/005175 |
Accord Healthcare S.L.U. |
2019/11/14
|
Authorised |
| Ivozall |
Human |
clofarabine |
clofarabine |
EMEA/H/C/005039 |
ORPHELIA Pharma |
2019/11/14
|
Withdrawn |
| Senstend |
Human |
lidocaine;prilocaine |
lidocaine;prilocaine |
EMEA/H/C/005298 |
Plethora Pharma Solutions Limited |
2019/11/14
|
Withdrawn |
| Ervebo |
Human |
Ebola Zaire vaccine (rVSV∆G-ZEBOV-GP, live) |
recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein |
EMEA/H/C/004554 |
Merck Sharp & Dohme B.V. |
2019/11/11
|
Authorised |
| Qtrilmet |
Human |
metformin hydrochloride;saxagliptin;dapagliflozin |
metformin hydrochloride;saxagliptin;dapagliflozin |
EMEA/H/C/004910 |
AstraZeneca AB |
2019/11/11
|
Withdrawn |
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