| Dimethyl fumarate Accord |
Human |
dimethyl fumarate |
dimethyl fumarate |
EMEA/H/C/006471 |
Accord Healthcare Ltd |
2024/04/22
|
Authorised |
| Dimethyl fumarate Mylan |
Human |
dimethyl fumarate |
dimethyl fumarate |
EMEA/H/C/006397 |
Mylan Ireland Limited |
2024/04/22
|
Authorised |
| Dimethyl fumarate Neuraxpharm |
Human |
dimethyl fumarate |
dimethyl fumarate |
EMEA/H/C/006500 |
Neuraxpharm Pharmaceuticals S.L. |
2024/04/22
|
Authorised |
| Zynyz |
Human |
retifanlimab |
retifanlimab |
EMEA/H/C/006194 |
Incyte Biosciences Distribution B.V. |
2024/04/19
|
Authorised |
| Voydeya |
Human |
danicopan |
Danicopan |
EMEA/H/C/005517 |
Alexion Europe SAS |
2024/04/19
|
Authorised |
| Apremilast Accord |
Human |
apremilast |
apremilast |
EMEA/H/C/006208 |
Accord Healthcare S.L.U. |
2024/04/19
|
Authorised |
| Filspari |
Human |
sparsentan |
sparsentan |
EMEA/H/C/005783 |
Vifor France |
2024/04/19
|
Authorised |
| Incellipan |
Human |
pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures) |
Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen |
EMEA/H/C/006051 |
Seqirus Netherlands B.V. |
2024/04/19
|
Authorised |
| Pyzchiva |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/006183 |
Samsung Bioepis NL B.V. |
2024/04/19
|
Authorised |
| Nintedanib Accord |
Human |
nintedanib |
nintedanib |
EMEA/H/C/006179 |
Accord Healthcare S.L.U. |
2024/04/19
|
Authorised |
| Celldemic |
Human |
zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures) |
Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen |
EMEA/H/C/006052 |
Seqirus Netherlands B.V. |
2024/04/19
|
Authorised |
| Tizveni |
Human |
tislelizumab |
tislelizumab |
EMEA/H/C/005542 |
BeiGene Ireland Ltd |
2024/04/19
|
Withdrawn |
| Niapelf |
Human |
paliperidone |
paliperidone palmitate |
EMEA/H/C/006185 |
Neuraxpharm Pharmaceuticals S.L. |
2024/03/31
|
Authorised |
| Ryzneuta |
Human |
efbemalenograstim alfa |
efbemalenograstim alfa |
EMEA/H/C/005828 |
Evive Biotechnology Ireland Limited |
2024/03/21
|
Authorised |
| Exblifep |
Human |
cefepime;enmetazobactam |
cefepime dihydrochloride monohydrate;Enmetazobactam |
EMEA/H/C/005431 |
Advanz Pharma Limited |
2024/03/21
|
Authorised |
| Dabigatran etexilate Teva (previously Dabigatran etexilate Leon Farma) |
Human |
dabigatran etexilate |
dabigatran etexilate mesilate |
EMEA/H/C/005922 |
Teva GmbH |
2024/02/19
|
Authorised |
| Velsipity |
Human |
etrasimod |
Etrasimod arginine |
EMEA/H/C/006007 |
Pfizer Europe MA EEIG |
2024/02/16
|
Authorised |
| Ibuprofen Gen.Orph |
Human |
ibuprofen |
Ibuprofen |
EMEA/H/C/006129 |
Gen.Orph |
2024/02/16
|
Authorised |
| Pomalidomide Viatris |
Human |
pomalidomide |
Pomalidomide |
EMEA/H/C/006195 |
Viatris Limited |
2024/02/16
|
Authorised |
| Skyclarys |
Human |
omaveloxolone |
omaveloxolone |
EMEA/H/C/006084 |
Biogen Netherlands B.V. |
2024/02/09
|
Authorised |