Ztalmy |
Human |
ganaxolone |
Ganaxolone |
EMEA/H/C/005825 |
Marinus Pharmaceuticals Emerald Limited |
2023/07/26
|
Authorised |
Pylclari |
Human |
piflufolastat (18F) |
Piflufolastat (18F) |
EMEA/H/C/005520 |
Curium Pet France |
2023/07/24
|
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 |
Opfolda |
Human |
miglustat |
miglustat |
EMEA/H/C/005695 |
Amicus Therapeutics Europe Limited |
2023/06/26
|
Authorised |
Camzyos |
Human |
mavacamten |
Mavacamten |
EMEA/H/C/005457 |
Bristol-Myers Squibb Pharma EEIG |
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 |
Briumvi |
Human |
ublituximab |
Ublituximab |
EMEA/H/C/005914 |
Neuraxpharm Pharmaceuticals S.L. |
2023/05/31
|
Authorised |
Lacosamide Adroiq |
Human |
lacosamide |
lacosamide |
EMEA/H/C/006047 |
Extrovis EU Ltd. |
2023/05/31
|
Authorised |
Pedmarqsi |
Human |
sodium thiosulfate |
Sodium thiosulfate |
EMEA/H/C/005130 |
Fennec Pharmaceuticals (EU) Limited |
2023/05/26
|
Authorised |
Sugammadex Adroiq |
Human |
sugammadex |
sugammadex sodium |
EMEA/H/C/006046 |
Extrovis EU Ltd. |
2023/05/26
|
Authorised |
Omvoh |
Human |
mirikizumab |
Mirikizumab |
EMEA/H/C/005122 |
Eli Lilly Nederland 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 |
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 |
Hyftor |
Human |
sirolimus |
Sirolimus |
EMEA/H/C/005896 |
Plusultra pharma GmbH |
2023/05/15
|
Authorised |
Tibsovo |
Human |
ivosidenib |
Ivosidenib |
EMEA/H/C/005936 |
Les Laboratoires Servier |
2023/05/04
|
Authorised |
Elfabrio |
Human |
pegunigalsidase alfa |
Pegunigalsidase alfa |
EMEA/H/C/005618 |
Chiesi Farmaceutici S.p.A |
2023/05/04
|
Authorised |
Vafseo |
Human |
vadadustat |
Vadadustat |
EMEA/H/C/005131 |
Akebia Europe Limited |
2023/04/24
|
Authorised |