| Arexvy |
Human |
recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E |
|
EMEA/H/C/006054 |
GlaxoSmithKline Biologicals S.A. |
2023/06/06
|
Authorised |
| Lacosamide Adroiq |
Human |
lacosamide |
lacosamide |
EMEA/H/C/006047 |
Extrovis EU Ltd |
2023/05/31
|
Authorised |
| Briumvi |
Human |
ublituximab |
ublituximab |
EMEA/H/C/005914 |
Neuraxpharm Pharmaceuticals S.L. |
2023/05/31
|
Authorised |
| Dabigatran Etexilate Accord |
Human |
dabigatran etexilate |
dabigatran etexilate mesilate |
EMEA/H/C/005639 |
Accord Healthcare S.L.U. |
2023/05/26
|
Authorised |
| Qaialdo |
Human |
spironolactone |
spironolactone |
EMEA/H/C/005535 |
Lipomed GmbH |
2023/05/26
|
Authorised |
| Epysqli |
Human |
eculizumab |
Eculizumab |
EMEA/H/C/006036 |
Samsung Bioepis NL B.V. |
2023/05/26
|
Authorised |
| Omvoh |
Human |
mirikizumab |
mirikizumab |
EMEA/H/C/005122 |
Eli Lilly Nederland B.V. |
2023/05/26
|
Authorised |
| Sugammadex Adroiq |
Human |
sugammadex |
sugammadex sodium |
EMEA/H/C/006046 |
Extrovis EU Ltd |
2023/05/26
|
Authorised |
| Pedmarqsi |
Human |
sodium thiosulfate |
sodium thiosulfate |
EMEA/H/C/005130 |
Norgine B.V. |
2023/05/26
|
Authorised |
| Hyftor |
Human |
sirolimus |
sirolimus |
EMEA/H/C/005896 |
Plusultra pharma GmbH |
2023/05/15
|
Authorised |
| Elfabrio |
Human |
pegunigalsidase alfa |
pegunigalsidase alfa |
EMEA/H/C/005618 |
Chiesi Farmaceutici S.p.A |
2023/05/04
|
Authorised |
| 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 |
| 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 |
| Bekemv |
Human |
eculizumab |
Eculizumab |
EMEA/H/C/005652 |
Amgen Technology (Ireland) UC |
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 |
| Sotyktu |
Human |
deucravacitinib |
deucravacitinib |
EMEA/H/C/005755 |
Bristol-Myers Squibb Pharma EEIG |
2023/03/24
|
Authorised |
| Dapagliflozin Viatris |
Human |
dapagliflozin |
dapagliflozin |
EMEA/H/C/006006 |
Viatris Limited |
2023/03/24
|
Authorised |
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