PRAC rapporteur post-authorisation-safety-study-protocol assessment-report template

Template PRAC assessment report of an non-interventional imposed PASS final study report

Human medicines European public assessment report (EPAR): Leqembi, lecanemab, Date of authorisation: 15/04/2025, Revision: 2, Status: Authorised

National competent authorities (human)

Human medicines European public assessment report (EPAR): Imraldi, adalimumab, Date of authorisation: 24/08/2017, Revision: 25, Status: Authorised

Human medicines European public assessment report (EPAR): Erleada, apalutamide, Date of authorisation: 14/01/2019, Revision: 20, Status: Authorised

List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)

Plasma Master File (PMF) requirements - questions and answers for PMF holders

List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment

Human medicines European public assessment report (EPAR): Sapropterin Dipharma, sapropterin, Date of authorisation: 16/02/2022, Revision: 7, Status: Authorised