| Dimethyl fumarate Polpharma |
Human |
dimethyl fumarate |
dimethyl fumarate |
EMEA/H/C/005955 |
Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A. |
2022/05/13
|
Revoked |
| Dimethyl fumarate Mylan |
Human |
dimethyl fumarate |
dimethyl fumarate |
EMEA/H/C/005956 |
Mylan Ireland Limited |
2022/05/13
|
Revoked |
| Amversio |
Human |
betaine anhydrous |
betaine |
EMEA/H/C/005637 |
SERB SA |
2022/05/05
|
Authorised |
| Orgovyx |
Human |
relugolix |
relugolix |
EMEA/H/C/005353 |
Accord Healthcare S.L.U. |
2022/04/29
|
Authorised |
| Quviviq |
Human |
daridorexant |
daridorexant hydrochloride |
EMEA/H/C/005634 |
Idorsia Pharmaceuticals Deutschland GmbH |
2022/04/29
|
Authorised |
| Kapruvia |
Human |
difelikefalin |
difelikefalin |
EMEA/H/C/005612 |
Vifor Fresenius Medical Care Renal Pharma France |
2022/04/25
|
Authorised |
| Uplizna |
Human |
inebilizumab |
inebilizumab |
EMEA/H/C/005818 |
Amgen Europe B.V. |
2022/04/25
|
Authorised |
| Vydura |
Human |
rimegepant |
rimegepant |
EMEA/H/C/005725 |
Pfizer Europe MA EEIG |
2022/04/25
|
Authorised |
| Sitagliptin Accord |
Human |
sitagliptin |
sitagliptin hydrochloride |
EMEA/H/C/005598 |
Accord Healthcare S.L.U. |
2022/04/25
|
Authorised |
| PreHevbri |
Human |
hepatitis B surface antigen |
hepatitis B surface antigen |
EMEA/H/C/005466 |
VBI Vaccines B.V. |
2022/04/25
|
Withdrawn |
| Truvelog Mix 30 |
Human |
insulin aspart |
insulin aspart |
EMEA/H/C/005635 |
Sanofi Winthrop Industrie |
2022/04/25
|
Authorised |
| Inpremzia |
Human |
insulin human (rDNA) |
insulin human (rDNA) |
EMEA/H/C/005331 |
Baxter Holding B.V. |
2022/04/25
|
Withdrawn |
| Padcev |
Human |
enfortumab vedotin |
Enfortumab vedotin |
EMEA/H/C/005392 |
Astellas Pharma Europe B.V. |
2022/04/13
|
Authorised |
| Breyanzi |
Human |
lisocabtagene maraleucel |
lisocabtagene maraleucel |
EMEA/H/C/004731 |
Bristol-Myers Squibb Pharma EEIG |
2022/04/04
|
Authorised |
| Kimmtrak |
Human |
tebentafusp |
tebentafusp |
EMEA/H/C/004929 |
Immunocore Ireland Limited |
2022/04/01
|
Authorised |
| Stimufend |
Human |
pegfilgrastim |
pegfilgrastim |
EMEA/H/C/004780 |
Fresenius Kabi Deutschland GmbH |
2022/03/28
|
Authorised |
| Evusheld |
Human |
tixagevimab;cilgavimab |
tixagevimab;cilgavimab |
EMEA/H/C/005788 |
AstraZeneca AB |
2022/03/25
|
Withdrawn |
| Vildagliptin / Metformin hydrochloride Accord |
Human |
vildagliptin;metformin hydrochloride |
metformin hydrochloride;vildagliptin |
EMEA/H/C/005738 |
Accord Healthcare S.L.U. |
2022/03/24
|
Authorised |
| Sondelbay |
Human |
teriparatide |
teriparatide |
EMEA/H/C/005827 |
Accord Healthcare S.L.U. |
2022/03/24
|
Authorised |
| Dasatinib Accord |
Human |
dasatinib (anhydrous) |
dasatinib |
EMEA/H/C/005446 |
Accord Healthcare S.L.U. |
2022/03/24
|
Withdrawn |