EMEA-003462-PIP01-23

EMEA-003572-PIP01-23

Opinion/decision on a Paediatric investigation plan (PIP): Aspaveli, Pegcetacoplan, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Renal and urinary disorders, PIP number: P/0195/2024

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

Scientific advice and protocol assistance adopted during the CHMP meeting 16-19 June 2025

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – June 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 26 June 2025, 10:00 (CEST) to 26 June 2025, 12:00 (CEST)

Human medicines European public assessment report (EPAR): Miglustat Dipharma, miglustat, Date of authorisation: 18/02/2019, Revision: 8, Status: Authorised

Fourteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 June 2025, 13:00 (CEST) to 23 June 2025, 18:00 (CEST)

European Platform for Regulatory Science Research

Foclivia : EPAR - All Authorised presentations