| Abrysvo |
Human |
respiratory syncytial virus vaccine (bivalent, recombinant) |
respiratory Syncytial Virus, subgroup A, stabilized prefusion F protein 847A;respiratory syncytial virus, subgroup B, stabilized prefusion F protein 847B |
EMEA/H/C/006027 |
Pfizer Europe MA EEIG |
2023/08/23
|
Authorised |
| Talvey |
Human |
talquetamab |
talquetamab |
EMEA/H/C/005864 |
Janssen-Cilag International N.V. |
2023/08/21
|
Authorised |
| Aquipta |
Human |
atogepant |
atogepant |
EMEA/H/C/005871 |
AbbVie Deutschland GmbH & Co. KG |
2023/08/11
|
Authorised |
| Ztalmy |
Human |
ganaxolone |
ganaxolone |
EMEA/H/C/005825 |
Marinus Pharmaceuticals Emerald Limited |
2023/07/26
|
Authorised |
| Columvi |
Human |
glofitamab |
Glofitamab |
EMEA/H/C/005751 |
Roche Registration GmbH |
2023/07/07
|
Authorised |
| Lytgobi |
Human |
futibatinib |
Futibatinib |
EMEA/H/C/005627 |
Taiho Pharma Netherlands B.V. |
2023/07/04
|
Authorised |
| Camzyos |
Human |
mavacamten |
Mavacamten |
EMEA/H/C/005457 |
Bristol-Myers Squibb Pharma EEIG |
2023/06/26
|
Authorised |
| Opfolda |
Human |
miglustat |
miglustat |
EMEA/H/C/005695 |
Amicus Therapeutics Europe Limited |
2023/06/26
|
Authorised |
| Sugammadex Piramal |
Human |
sugammadex |
sugammadex sodium |
EMEA/H/C/006083 |
Piramal Critical Care B.V. |
2023/06/23
|
Authorised |
| Arexvy |
Human |
recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E |
Respiratory Syncytial Virus recombinant glycoprotein F stabilised in the pre-fusion conformation (RSVPreF3) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology |
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 |
| 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 |
| Epysqli |
Human |
|
Eculizumab |
EMEA/H/C/006036 |
Samsung Bioepis NL B.V. |
2023/05/26
|
Authorised |
| Qaialdo |
Human |
spironolactone |
spironolactone |
EMEA/H/C/005535 |
Nova Laboratories Ireland Limited |
2023/05/26
|
Authorised |
| Pedmarqsi |
Human |
sodium thiosulfate |
sodium thiosulfate |
EMEA/H/C/005130 |
Norgine B.V. |
2023/05/26
|
Authorised |
| Dabigatran Etexilate Accord |
Human |
dabigatran etexilate |
dabigatran etexilate mesilate |
EMEA/H/C/005639 |
Accord Healthcare S.L.U. |
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 |