| 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Withdrawn |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 |
| Pomalidomide Viatris |
Human |
pomalidomide |
Pomalidomide |
EMEA/H/C/006195 |
Viatris Limited |
2024/02/16
|
Authorised |
| Ibuprofen Gen.Orph |
Human |
ibuprofen |
Ibuprofen |
EMEA/H/C/006129 |
Gen.Orph |
2024/02/16
|
Authorised |
| Velsipity |
Human |
etrasimod |
Etrasimod arginine |
EMEA/H/C/006007 |
Pfizer Europe MA EEIG |
2024/02/16
|
Authorised |
| Skyclarys |
Human |
omaveloxolone |
omaveloxolone |
EMEA/H/C/006084 |
Biogen Netherlands B.V. |
2024/02/09
|
Authorised |
| Casgevy |
Human |
exagamglogene autotemcel |
Exagamglogene autotemcel |
EMEA/H/C/005763 |
Vertex Pharmaceuticals (Ireland) Limited |
2024/02/09
|
Authorised |
| Mevlyq |
Human |
eribulin |
Eribulin mesylate |
EMEA/H/C/006134 |
YES Pharmaceutical Development Services GmbH |
2024/02/09
|
Authorised |
| Omjjara |
Human |
momelotinib |
Momelotinib dihydrochloride monohydrate |
EMEA/H/C/005768 |
GlaxoSmithKline Trading Services Limited |
2024/01/25
|
Authorised |
| Spexotras |
Human |
trametinib |
trametinib dimethyl sulfoxide |
EMEA/H/C/005886 |
Novartis Europharm Limited |
2024/01/05
|
Authorised |
| Uzpruvo |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/006101 |
Stada Arzneimittel AG |
2024/01/05
|
Authorised |
| Rystiggo |
Human |
rozanolixizumab |
rozanolixizumab |
EMEA/H/C/005824 |
UCB Pharma |
2024/01/05
|
Authorised |
| Rimmyrah |
Human |
ranibizumab |
ranibizumab |
EMEA/H/C/006055 |
Qilu Pharma Spain S.L. |
2024/01/05
|
Authorised |
| Azacitidine Kabi |
Human |
azacitidine |
azacitidine |
EMEA/H/C/006154 |
Fresenius Kabi Deutschland GmbH |
2024/01/05
|
Authorised |
| Krazati |
Human |
adagrasib |
adagrasib |
EMEA/H/C/006013 |
Bristol-Myers Squibb Pharma EEIG |
2024/01/05
|
Authorised |