Accelerating Clinical Trials in the EU (ACT EU)

Human medicines European public assessment report (EPAR): Qdenga, dengue tetravalent vaccine (live, attenuated), Date of authorisation: 05/12/2022, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR): Verzenios, abemaciclib, Date of authorisation: 26/09/2018, Revision: 19, Status: Authorised

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

Human medicines European public assessment report (EPAR): Opdualag, relatlimab,nivolumab, Date of authorisation: 15/09/2022, Revision: 8, Status: Authorised

Timetable: Annual renewal application of conditional marketing authorisation

Timetable: Annual reassessment - ATMP

Timetable: Annual reassessment

Timetable: Annual renewal application of conditional marketing authorisation - ATMP