| 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Withdrawn |
| Inbrija |
Human |
levodopa |
levodopa |
EMEA/H/C/004786 |
Merz Therapeutics GmbH |
2019/09/19
|
Authorised |
| 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 |
| 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Withdrawn |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 |
| Posaconazole AHCL |
Human |
posaconazole |
posaconazole |
EMEA/H/C/005028 |
Accord Healthcare S.L.U. |
2019/07/25
|
Authorised |
| Ultomiris |
Human |
ravulizumab |
ravulizumab |
EMEA/H/C/004954 |
Alexion Europe SAS |
2019/07/02
|
Authorised |
| Dovato |
Human |
dolutegravir;lamivudine |
dolutegravir sodium;lamivudine |
EMEA/H/C/004909 |
ViiV Healthcare B.V. |
2019/07/01
|
Authorised |
| Xromi |
Human |
hydroxycarbamide |
hydroxycarbamide |
EMEA/H/C/004837 |
Lipomed GmbH |
2019/07/01
|
Authorised |
| Libtayo |
Human |
cemiplimab |
cemiplimab |
EMEA/H/C/004844 |
Regeneron Ireland Designated Activity Company (DAC) |
2019/06/28
|
Authorised |
| Striascan |
Human |
ioflupane (123l) |
ioflupane (123l) |
EMEA/H/C/004745 |
CIS bio international |
2019/06/25
|
Authorised |
| Ambrisentan Viatris (previously Ambrisentan Mylan) |
Human |
ambrisentan |
ambrisentan |
EMEA/H/C/004985 |
Viatris Limited |
2019/06/20
|
Authorised |
| Grasustek |
Human |
pegfilgrastim |
pegfilgrastim |
EMEA/H/C/004556 |
Juta Pharma GmbH |
2019/06/20
|
Authorised |
| Talzenna |
Human |
talazoparib |
talazoparib |
EMEA/H/C/004674 |
Pfizer Europe MA EEIG |
2019/06/20
|
Authorised |