PSUSA/00001324/202505
PSUSA/00001324/202505
PSUSA/00001324/202505
PSUSA/00001040/202507
PSUSA/00002149/202505
PSUSA/00001672/202508
Human medicines European public assessment report (EPAR): Deltyba, delamanid, Date of authorisation: 27/04/2014, Date of refusal: 25/07/2013, Revision: 28, Status: Authorised
Human medicines European public assessment report (EPAR): Strensiq, asfotase alfa, Date of authorisation: 28/08/2015, Revision: 18, Status: Authorised
PSUSA/00003146/202507
PSUSA/00001476/202508
New PRIME tools to accelerate development of medicines in the EU
Opinion on medicine for use outside EU: Mosquirix, RTS,S [Portion of P. falciparum circumsporozoite protein fused with hepatitis B surface antigen (RTS), and combined with hepatitis B surface antigen (S)], Malaria, 23/07/2015 Positive opinion