| Nuvaxovid |
Human |
COVID-19 Vaccine (recombinant, adjuvanted) |
SARS CoV-2 (Original) recombinant spike protein;SARS-CoV-2 (Omicron XBB.1.5) recombinant spike protein |
EMEA/H/C/005808 |
Sanofi Winthrop Industrie |
2021/12/20
|
Authorised |
| Xevudy |
Human |
sotrovimab |
sotrovimab |
EMEA/H/C/005676 |
GlaxoSmithKline Trading Services Limited |
2021/12/17
|
Authorised |
| Aspaveli |
Human |
pegcetacoplan |
pegcetacoplan |
EMEA/H/C/005553 |
Swedish Orphan Biovitrum AB (publ) |
2021/12/13
|
Authorised |
| Vaxneuvance |
Human |
pneumococcal polysaccharide conjugate vaccine (adsorbed) |
pneumococcal polysaccharide conjugate vaccine (adsorbed) |
EMEA/H/C/005477 |
Merck Sharp & Dohme B.V. |
2021/12/13
|
Authorised |
| Cibinqo |
Human |
abrocitinib |
abrocitinib |
EMEA/H/C/005452 |
Pfizer Europe MA EEIG |
2021/12/09
|
Authorised |
| Sitagliptin SUN |
Human |
sitagliptin fumarate |
sitagliptin fumarate |
EMEA/H/C/005741 |
Sun Pharmaceutical Industries Europe B.V. |
2021/12/09
|
Authorised |
| Rybrevant |
Human |
amivantamab |
amivantamab |
EMEA/H/C/005454 |
Janssen-Cilag International N.V. |
2021/12/09
|
Authorised |
| Brukinsa |
Human |
zanubrutinib |
zanubrutinib |
EMEA/H/C/004978 |
BeOne Medicines Ireland Limited |
2021/11/22
|
Authorised |
| Trodelvy |
Human |
sacituzumab govitecan |
sacituzumab govitecan |
EMEA/H/C/005182 |
Gilead Sciences Ireland UC |
2021/11/22
|
Authorised |
| Artesunate Amivas |
Human |
artesunate |
artesunate |
EMEA/H/C/005550 |
Amivas Ireland Ltd |
2021/11/22
|
Authorised |
| Qinlock |
Human |
ripretinib |
ripretinib |
EMEA/H/C/005614 |
Deciphera Pharmaceuticals (Netherlands) B.V. |
2021/11/18
|
Authorised |
| Gavreto |
Human |
pralsetinib |
pralsetinib |
EMEA/H/C/005413 |
Blueprint Medicines (Netherlands) B.V. |
2021/11/18
|
Withdrawn |
| Hukyndra |
Human |
adalimumab |
adalimumab |
EMEA/H/C/005548 |
Stada Arzneimittel AG |
2021/11/15
|
Authorised |
| Sugammadex Mylan |
Human |
sugammadex |
sugammadex sodium |
EMEA/H/C/005403 |
Mylan Pharmaceuticals Limited |
2021/11/15
|
Authorised |
| Vumerity |
Human |
diroximel fumarate |
Diroximel fumarate (BIIB098) |
EMEA/H/C/005437 |
Biogen Netherlands B.V. |
2021/11/15
|
Authorised |
| Ronapreve |
Human |
casirivimab;imdevimab |
casirivimab;imdevimab |
EMEA/H/C/005814 |
Roche Registration GmbH |
2021/11/12
|
Withdrawn |
| Libmyris |
Human |
adalimumab |
adalimumab |
EMEA/H/C/005947 |
Stada Arzneimittel AG |
2021/11/12
|
Authorised |
| Rivaroxaban Viatris (previously Rivaroxaban Mylan) |
Human |
rivaroxaban |
rivaroxaban |
EMEA/H/C/005600 |
Viatris Limited |
2021/11/12
|
Authorised |
| Regkirona |
Human |
regdanvimab |
regdanvimab |
EMEA/H/C/005854 |
Celltrion Healthcare Hungary Kft. |
2021/11/12
|
Withdrawn |
| Imatinib Koanaa |
Human |
imatinib |
imatinib mesilate |
EMEA/H/C/005595 |
Koanaa Healthcare GmbH |
2021/09/22
|
Withdrawn |