PSUSA/00010606/202506
PSUSA/00010606/202506
PSUSA/00010606/202506
Human medicines European public assessment report (EPAR): Pregabalin Zentiva, pregabalin, Date of authorisation: 17/07/2015, Revision: 19, Status: Authorised
Committee for Orphan Medicinal Products (COMP): 17-19 February 2026, European Medicines Agency, Amsterdam, the Netherlands, from 17 February 2026 to 19 February 2026
Human medicines European public assessment report (EPAR): Orphacol, cholic acid, Date of authorisation: 12/09/2013, Revision: 16, Status: Authorised
Human medicines European public assessment report (EPAR): Dovato, dolutegravir,lamivudine, Date of authorisation: 01/07/2019, Revision: 20, Status: Authorised
PSUSA/00010572/202506
Human medicines European public assessment report (EPAR): Luxturna, voretigene neparvovec, Date of authorisation: 22/11/2018, Revision: 12, Status: Authorised
Human medicines European public assessment report (EPAR): Jemperli, dostarlimab, Date of authorisation: 21/04/2021, Revision: 14, Status: Authorised
Overview of comments received on Q&A regarding co-processed excipients used in solid oral dosage forms H and V (EMA/CHMP/CVMP/QWP/422493/2024)
ICH E20 adaptive designs for clinical trials - Scientific guideline