Timetable: Marketing authorisation renewal application
Timetable: Marketing authorisation renewal application
Timetable: Marketing authorisation renewal application
PSUSA/00002478/202508
PSUSA/00001819/202509
European Medicines Agency (EMA) / European Chemicals Agency (ECHA) joint meeting with industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 9 June 2026, 09:00 (CEST) to 9 June 2026, 12:00 (CEST)
Accelerating Clinical Trials in the EU (ACT EU)
Human medicines European public assessment report (EPAR): Sunosi, solriamfetol, Date of authorisation: 16/01/2020, Revision: 11, Status: Authorised
Human medicines European public assessment report (EPAR): Xenleta, lefamulin, Date of authorisation: 27/07/2020, Revision: 3, Status: Authorised
Timetable: Annual renewal application of conditional marketing authorisation
Timetable: Annual reassessment - ATMP
Timetable: Annual reassessment