EMEA-002656-PIP01-19-M01
EMEA-002656-PIP01-19-M01
EMEA-002656-PIP01-19-M01
List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)
Joint HTAb-regulatory perspectives on understanding evidence challenges, managing uncertainties and exploring potential solutions
Tolvaptan product-specific bioequivalence guidance
EMEA-000551-PIP04-21-M03
Opinion/decision on a Paediatric investigation plan (PIP): Quviviq, Daridorexant, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Nervous system disorders, PIP number: P/0054/2024
Opinion/decision on a Paediatric investigation plan (PIP): Edarbi, Azilsartan medoxomil, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vascular disorders, PIP number: P/0053/2024
EMEA-002234-PIP01-17-M02
Rules of procedure for the Patients and Consumers Working Party (PCWP) and the Healthcare Professionals Working Party (HCPWP)
Mandate, objectives and composition of the Patients and Consumers Working Party (PCWP)