Human medicines European public assessment report (EPAR): Idelvion, albutrepenonacog alfa, Hemophilia B, Date of authorisation: 11/05/2016, Revision: 12, Status: Authorised
Timetable: Annual renewal application of conditional marketing authorisation
Opinion/decision on a Paediatric investigation plan (PIP): Dovato,lamivudine,dolutegravir, decision type: , therapeutic area: , PIP number: P/0391/2022
Timetable: Annual reassessment
Opinion/decision on a Paediatric investigation plan (PIP): Copanlisib, decision type: , therapeutic area: , PIP number: P/0385/2022
Timetable: Marketing authorisation renewal application
Opinion/decision on a Paediatric investigation plan (PIP): Zeposia,Ozanimod (hydrochloride), decision type: , therapeutic area: , PIP number: P/0392/2022
Opinion/decision on a Paediatric investigation plan (PIP): Crysvita,Burosumab, decision type: , therapeutic area: , PIP number: P/0411/2022
Compilation of Union procedures on inspections and exchange of information
CTIS newsflash - 15 September 2023