Review of the stepwise paediatric investigation plan (sPIP) pilot: Outcomes and future perspectives
Review of the stepwise paediatric investigation plan (sPIP) pilot: Outcomes and future perspectives
Review of the stepwise paediatric investigation plan (sPIP) pilot: Outcomes and future perspectives
Paediatric investigation plans
Human medicines European public assessment report (EPAR): Vantavo (previously Alendronate sodium and colecalciferol, MSD), alendronic acid,colecalciferol, Date of authorisation: 16/10/2009, Revision: 22, Status: Authorised
Human medicines European public assessment report (EPAR): Palforzia, defatted powder of Arachis hypogaea L., semen (peanuts), Date of authorisation: 17/12/2020, Revision: 11, Status: Authorised
Quarterly System Demo - Q1 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 26 March 2026, 09:00 (CET) to 26 March 2026, 12:45 (CET)
PSUSA/00002076/202506
PSUSA/00000812/202506
PSUSA/00002639/202507
Q&A clinic on Substance, Organisation, Referentials Management Services - March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 10 March 2026, 11:00 (CET) to 10 March 2026, 12:00 (CET)
Guidance for applicants for the preparation of the precise scope section of the variation application form