List of centrally authorised products requiring a notification of a change for update of annexes

Methodology European Specialised Expert Community (ESEC)

EMEA-002741-PIP01-20-M01

Cancer medicines forum meeting 4 December 2023, European Medicines Agency, Amsterdam, the Netherlands, 4 December 2023

Opinion/decision on a Paediatric investigation plan (PIP): Reagila, Cariprazine (hydrochloride), decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP, therapeutic area: Psychiatry, PIP number: P/0061/2023

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

List of medicinal products under additional monitoring

List of medicinal products under additional monitoring

Procedural advice for requests for the classification of variations not already listed in Commission Implementing Regulation (EU) 2021/17 or EMA/CMDv guidance on the details of the classification of variations requiring assessment according to Article 62

Timetable: Extension application