| 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Withdrawn |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 |
| Doptelet |
Human |
avatrombopag |
avatrombopag maleate |
EMEA/H/C/004722 |
Swedish Orphan Biovitrum AB (publ) |
2019/06/20
|
Authorised |
| Esperoct |
Human |
turoctocog alfa pegol |
turoctocog alfa pegol |
EMEA/H/C/004883 |
Novo Nordisk A/S |
2019/06/20
|
Authorised |
| Trecondi |
Human |
treosulfan |
treosulfan |
EMEA/H/C/004751 |
medac Gesellschaft für klinische Spezialpräparate mbH |
2019/06/20
|
Authorised |
| Sixmo |
Human |
buprenorphine |
buprenorphine hydrochloride |
EMEA/H/C/004743 |
L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A. |
2019/06/19
|
Withdrawn |
| Temybric Ellipta |
Human |
fluticasone furoate;umeclidinium;vilanterol |
fluticasone furoate;umeclidinium bromide;vilanterol trifenatate |
EMEA/H/C/005254 |
GlaxoSmithKline Trading Services Limited |
2019/06/12
|
Lapsed |
| Zynteglo |
Human |
betibeglogene autotemcel |
autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene |
EMEA/H/C/003691 |
bluebird bio (Netherlands) B.V. |
2019/05/29
|
Withdrawn |
| Frontpro (previously Afoxolaner Merial) |
Veterinary |
afoxolaner |
afoxolaner |
EMEA/V/C/005126 |
|
2019/05/20
|
Authorised |