| Rhokiinsa |
Human |
netarsudil |
netarsudil |
EMEA/H/C/004583 |
Santen Oy |
2019/11/19
|
Authorised |
| Arsenic trioxide Accord |
Human |
arsenic trioxide |
arsenic trioxide |
EMEA/H/C/005175 |
Accord Healthcare S.L.U. |
2019/11/14
|
Authorised |
| Bortezomib Fresenius Kabi |
Human |
bortezomib |
bortezomib |
EMEA/H/C/005074 |
Fresenius Kabi Deutschland GmbH |
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Withdrawn |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Withdrawn |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Withdrawn |
| Xospata |
Human |
gilteritinib |
gilteritinib fumarate |
EMEA/H/C/004752 |
Astellas Pharma Europe B.V. |
2019/10/24
|
Authorised |
| Nuceiva |
Human |
botulinum toxin type a |
Botulinum toxin type A |
EMEA/H/C/004587 |
Evolus Pharma B.V. |
2019/09/27
|
Authorised |
| Deferasirox Mylan |
Human |
deferasirox |
deferasirox |
EMEA/H/C/005014 |
Mylan Pharmaceuticals Limited |
2019/09/26
|
Authorised |
| Trogarzo |
Human |
ibalizumab |
Ibalizumab |
EMEA/H/C/004961 |
Theratechnologies Europe Limited |
2019/09/26
|
Withdrawn |
| Vitrakvi |
Human |
larotrectinib |
larotrectinib sulfate |
EMEA/H/C/004919 |
Bayer AG |
2019/09/19
|
Authorised |
| Epidyolex |
Human |
cannabidiol |
cannabidiol |
EMEA/H/C/004675 |
Jazz Pharmaceuticals Ireland Limited |
2019/09/19
|
Authorised |
| Inbrija |
Human |
levodopa |
levodopa |
EMEA/H/C/004786 |
Merz Therapeutics GmbH |
2019/09/19
|
Authorised |
| Lacosamide UCB |
Human |
lacosamide |
lacosamide |
EMEA/H/C/005243 |
UCB Pharma S.A. |
2019/08/26
|
Authorised |
| Giapreza |
Human |
angiotensin II |
angiotensin II acetate |
EMEA/H/C/004930 |
Paion Pharma GmbH |
2019/08/23
|
Authorised |
| Azacitidine Celgene |
Human |
azacitidine |
azacitidine |
EMEA/H/C/005300 |
Celgene Europe BV |
2019/08/02
|
Withdrawn |
| LysaKare |
Human |
arginine;lysine |
L-arginine hydrochloride;L-lysine hydrochloride |
EMEA/H/C/004541 |
Advanced Accelerator Applications |
2019/07/25
|
Authorised |
| Cufence |
Human |
trientine dihydrochloride |
trientine dihydrochloride |
EMEA/H/C/004111 |
Univar Solutions BV |
2019/07/25
|
Authorised |
| Posaconazole Accord |
Human |
posaconazole |
posaconazole |
EMEA/H/C/005005 |
Accord Healthcare S.L.U. |
2019/07/25
|
Authorised |