Questions and answers about the clinical study data proof-of-concept pilot for industry
Pharmacovigilance Risk Assessment Committee (PRAC): 7 - 10 July 2025, European Medicines Agency, Amsterdam, the Netherlands, from 7 July 2025 to 10 July 2025
EMEA-003241-PIP01-22-M01
Agenda of the PRAC meeting 7-10 July 2025
EMEA-002780-PIP02-20-M02
EMEA-002703-PIP01-19-M01
EMEA-002689-PIP02-23-M01
EMEA-001957-PIP02-19-M01
Opinion/decision on a Paediatric investigation plan (PIP): Vyvgart, Efgartigimod alfa, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Nervous system disorders, PIP number: P/0298/2024
Opinion/decision on a Paediatric investigation plan (PIP): Elucirem, Gadopiclenol, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vascular disorders, PIP number: P/0294/2024