Timetable: Marketing authorisation renewal application - ATMP
Timetable: Marketing authorisation renewal application - ATMP
Timetable: Marketing authorisation renewal application - ATMP
Marketing authorisation renewal application - ATMP: Initial 90-day assessment
Timetable: Type II variation and worksharing application assessment - ATMP
Timetable: Type IB variation requiring linguistic review
Human medicines European public assessment report (EPAR): Zolgensma, onasemnogene abeparvovec, Muscular Atrophy, Spinal, Date of authorisation: 18/05/2020, Revision: 13, Status: Authorised
Human medicines European public assessment report (EPAR): Modigraf, tacrolimus, Graft Rejection, Date of authorisation: 15/05/2009, Revision: 19, Status: Authorised
Human medicines European public assessment report (EPAR): Myalepta, metreleptin, Lipodystrophy, Familial Partial, Date of authorisation: 29/07/2018, Revision: 9, Status: Authorised
Draft guideline on the development and manufacture of Synthetic Peptides
EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic pens
European Medicines Agency mid-year report 2023 (January-June 2023)