Akeega |
Human |
niraparib, abiraterone acetate |
abiraterone acetate, Niraparib tosilate monohydrate |
EMEA/H/C/005932 |
Janssen-Cilag International N.V. |
2023/04/19
|
Authorised |
Bekemv |
Human |
eculizumab |
Eculizumab |
EMEA/H/C/005652 |
Amgen Technology (Ireland) UC |
2023/04/19
|
Authorised |
Opzelura |
Human |
ruxolitinib |
ruxolitinib phosphate |
EMEA/H/C/005843 |
Incyte Biosciences Distribution B.V. |
2023/04/19
|
Authorised |
Sitagliptin / Metformin hydrochloride Sun |
Human |
sitagliptin, metformin hydrochloride |
sitagliptin fumarate, metformin hydrochloride |
EMEA/H/C/005778 |
Sun Pharmaceutical Industries Europe B.V. |
2023/03/31
|
Authorised |
Bimervax |
Human |
COVID-19 Vaccine (recombinant, adjuvanted) |
SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains |
EMEA/H/C/006058 |
Hipra Human Health S.L. |
2023/03/30
|
Authorised |
Dapagliflozin Viatris |
Human |
dapagliflozin |
dapagliflozin |
EMEA/H/C/006006 |
Viatris Limited |
2023/03/24
|
Authorised |
Sotyktu |
Human |
deucravacitinib |
Deucravacitinib |
EMEA/H/C/005755 |
Bristol-Myers Squibb Pharma EEIG |
2023/03/24
|
Authorised |
Pombiliti |
Human |
cipaglucosidase alfa |
Cipaglucosidase alfa |
EMEA/H/C/005703 |
Amicus Therapeutics Europe Limited |
2023/03/20
|
Authorised |
Imjudo |
Human |
tremelimumab |
Tremelimumab |
EMEA/H/C/006016 |
AstraZeneca AB |
2023/02/20
|
Authorised |
Tremelimumab AstraZeneca |
Human |
tremelimumab |
Tremelimumab |
EMEA/H/C/004650 |
AstraZeneca AB |
2023/02/20
|
Authorised |
Hemgenix |
Human |
etranacogene dezaparvovec |
Etranacogene dezaparvovec |
EMEA/H/C/004827 |
CSL Behring GmbH |
2023/02/20
|
Authorised |
Dimethyl fumarate Accord |
Human |
dimethyl fumarate |
dimethyl fumarate |
EMEA/H/C/005950 |
Accord Healthcare S.L.U. |
2023/02/15
|
Authorised |
Kauliv |
Human |
teriparatide |
teriparatide |
EMEA/H/C/004932 |
Strides Pharma (Cyprus) Limited |
2023/01/12
|
Authorised |
Pirfenidone Viatris |
Human |
pirfenidone |
Pirfenidone |
EMEA/H/C/005862 |
Viatris Limited |
2023/01/10
|
Authorised |
Sugammadex Amomed |
Human |
sugammadex |
sugammadex sodium |
EMEA/H/C/005935 |
AOP Orphan Pharmaceuticals GmbH |
2023/01/10
|
Authorised |
Zynlonta |
Human |
loncastuximab tesirine |
loncastuximab tesirine |
EMEA/H/C/005685 |
Swedish Orphan Biovitrum AB |
2022/12/20
|
Authorised |
Plerixafor Accord |
Human |
plerixafor |
Plerixafor |
EMEA/H/C/005943 |
Accord Healthcare S.L.U. |
2022/12/16
|
Authorised |
Ebvallo |
Human |
tabelecleucel |
Tabelecleucel |
EMEA/H/C/004577 |
Pierre Fabre Medicament |
2022/12/16
|
Authorised |
Dimethyl fumarate Teva |
Human |
dimethyl fumarate |
dimethyl fumarate |
EMEA/H/C/005963 |
Teva GmbH |
2022/12/12
|
Authorised |
Eladynos |
Human |
abaloparatide |
abaloparatide |
EMEA/H/C/005928 |
Theramex Ireland Limited |
2022/12/12
|
Authorised |