| Tibsovo |
Human |
ivosidenib |
Ivosidenib |
EMEA/H/C/005936 |
Les Laboratoires Servier |
2023/05/04
|
Authorised |
| Vafseo |
Human |
vadadustat |
vadadustat |
EMEA/H/C/005131 |
Medice Arzneimittel Pütter GmbH & Co. KG |
2023/04/24
|
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 |
| Akeega |
Human |
niraparib;abiraterone acetate |
abiraterone acetate;niraparib (tosilate monohydrate) |
EMEA/H/C/005932 |
Janssen-Cilag International N.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 dimer produced by recombinant DNA technology |
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 |
| Hemgenix |
Human |
etranacogene dezaparvovec |
Etranacogene dezaparvovec |
EMEA/H/C/004827 |
CSL Behring GmbH |
2023/02/20
|
Authorised |
| Tremelimumab AstraZeneca |
Human |
tremelimumab |
tremelimumab |
EMEA/H/C/004650 |
AstraZeneca AB |
2023/02/20
|
Withdrawn |
| Dimethyl fumarate Accord |
Human |
dimethyl fumarate |
dimethyl fumarate |
EMEA/H/C/005950 |
Accord Healthcare S.L.U. |
2023/02/15
|
Revoked |
| Kauliv |
Human |
teriparatide |
teriparatide |
EMEA/H/C/004932 |
Strides Pharma (Cyprus) Limited |
2023/01/12
|
Authorised |
| Sugammadex Amomed |
Human |
sugammadex |
sugammadex sodium |
EMEA/H/C/005935 |
AOP Orphan Pharmaceuticals GmbH |
2023/01/10
|
Authorised |
| Pirfenidone Viatris |
Human |
pirfenidone |
Pirfenidone |
EMEA/H/C/005862 |
Viatris Limited |
2023/01/10
|
Authorised |
| Zynlonta |
Human |
loncastuximab tesirine |
loncastuximab tesirine |
EMEA/H/C/005685 |
Swedish Orphan Biovitrum AB |
2022/12/20
|
Authorised |
| Ebvallo |
Human |
tabelecleucel |
tabelecleucel |
EMEA/H/C/004577 |
Pierre Fabre Medicament |
2022/12/16
|
Authorised |
| Plerixafor Accord |
Human |
plerixafor |
Plerixafor |
EMEA/H/C/005943 |
Accord Healthcare S.L.U. |
2022/12/16
|
Authorised |
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