| 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Withdrawn |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Withdrawn |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Withdrawn |
| Dasatinib Accordpharma |
Human |
dasatinib (anhydrous) |
dasatinib |
EMEA/H/C/005317 |
Accord Healthcare S.L.U. |
2022/03/24
|
Withdrawn |
| Ontilyv |
Human |
opicapone |
opicapone |
EMEA/H/C/005782 |
Bial Portela & Companhia S.A. |
2022/02/21
|
Lapsed |
| Sapropterin Dipharma |
Human |
sapropterin |
sapropterin dihydrochloride |
EMEA/H/C/005646 |
Dipharma Arzneimittel GmbH |
2022/02/16
|
Authorised |
| Sitagliptin / Metformin hydrochloride Mylan |
Human |
sitagliptin hydrochloride monohydrate;metformin hydrochloride |
sitagliptin hydrochloride monohydrate;metformin hydrochloride |
EMEA/H/C/005678 |
Mylan Pharmaceuticals Limited |
2022/02/16
|
Authorised |
| Kerendia |
Human |
finerenone |
Finerenone |
EMEA/H/C/005200 |
Bayer AG |
2022/02/16
|
Authorised |
| Tepmetko |
Human |
tepotinib |
tepotinib hydrochloride monohydrate |
EMEA/H/C/005524 |
Merck Europe B.V. |
2022/02/16
|
Authorised |
| Saphnelo |
Human |
anifrolumab |
anifrolumab |
EMEA/H/C/004975 |
AstraZeneca AB |
2022/02/14
|
Authorised |
| Ngenla |
Human |
somatrogon |
somatrogon |
EMEA/H/C/005633 |
Pfizer Europe MA EEIG |
2022/02/14
|
Authorised |
| Prevenar 20 (previously Apexxnar) |
Human |
pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) |
Pneumococcal polysaccharide serotype 1;Pneumococcal polysaccharide serotype 3;Pneumococcal polysaccharide serotype 4;Pneumococcal polysaccharide serotype 5;Pneumococcal polysaccharide serotype 6A;Pneumococcal polysaccharide serotype 6B;Pneumococcal polysaccharide serotype 7F;Pneumococcal polysaccharide serotype 8;Pneumococcal polysaccharide serotype 9V;Pneumococcal polysaccharide serotype 10A;Pneumococcal polysaccharide serotype 11A;pneumococcal polysaccharide serotype 12F;Pneumococcal polysaccharide serotype 14;Pneumococcal polysaccharide serotype 15b;Pneumococcal polysaccharide serotype 18C;Pneumococcal polysaccharide serotype 19A;Pneumococcal polysaccharide serotype 19F;Pneumococcal polysaccharide serotype 22F;Pneumococcal polysaccharide serotype 23F;Pneumococcal polysaccharide serotype 33F |
EMEA/H/C/005451 |
Pfizer Europe MA EEIG |
2022/02/14
|
Authorised |
| Okedi |
Human |
risperidone |
risperidone |
EMEA/H/C/005406 |
Laboratorios Farmacéuticos Rovi, S.A. |
2022/02/14
|
Authorised |
| Oxbryta |
Human |
voxelotor |
voxelotor |
EMEA/H/C/004869 |
Pfizer Europe MA EEIG |
2022/02/14
|
Suspended |