| Tabrecta |
Human |
capmatinib |
capmatinib dihydrochloride monohydrate |
EMEA/H/C/004845 |
Novartis Europharm Limited |
2022/06/20
|
Authorised |
| Pirfenidone axunio (previously Pirfenidone AET) |
Human |
pirfenidone |
Pirfenidone |
EMEA/H/C/005873 |
Axunio Pharma GmbH |
2022/06/20
|
Authorised |
| Yselty |
Human |
linzagolix choline |
linzagolix choline |
EMEA/H/C/005442 |
Theramex Ireland Limited |
2022/06/14
|
Authorised |
| Lunsumio |
Human |
mosunetuzumab |
mosunetuzumab |
EMEA/H/C/005680 |
Roche Registration GmbH |
2022/06/03
|
Authorised |
| Zolsketil pegylated liposomal |
Human |
doxorubicin |
doxorubicin hydrochloride, liposomal |
EMEA/H/C/005320 |
Accord Healthcare S.L.U. |
2022/05/31
|
Authorised |
| Carvykti |
Human |
ciltacabtagene autoleucel |
ciltacabtagene autoleucel |
EMEA/H/C/005095 |
Janssen-Cilag International NV |
2022/05/25
|
Authorised |
| Camcevi |
Human |
leuprorelin |
leuprorelin mesilate |
EMEA/H/C/005034 |
Accord Healthcare S.L.U. |
2022/05/24
|
Authorised |
| Amifampridine SERB |
Human |
amifampridine |
amifampridine phosphate |
EMEA/H/C/005839 |
SERB SA |
2022/05/19
|
Authorised |
| Dimethyl fumarate Neuraxpharm |
Human |
dimethyl fumarate |
dimethyl fumarate |
EMEA/H/C/006039 |
Laboratorios Lesvi S.L. |
2022/05/13
|
Revoked |
| 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 |
| 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Withdrawn |
| Kapruvia |
Human |
difelikefalin |
difelikefalin |
EMEA/H/C/005612 |
Vifor Fresenius Medical Care Renal Pharma France |
2022/04/25
|
Authorised |
| Truvelog Mix 30 |
Human |
insulin aspart |
insulin aspart |
EMEA/H/C/005635 |
Sanofi Winthrop Industrie |
2022/04/25
|
Authorised |