List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)
Third European Medicines Agency (EMA) and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 7 November 2024
Highlights - Third European Medicines Agency (EMA) and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) bilateral meeting
Human medicines European public assessment report (EPAR): Firdapse (previously Zenas), amifampridine, Date of authorisation: 23/12/2009, Revision: 22, Status: Authorised
Keppra
A common EU approach to data transparency in medicine regulation
Heads of Medicines Agencies / European Medicines Agency guidance document on the identification of commercially confidential information and personal data within the structure of the marketing-authorisation application: ...
Call for expression of interest for Academia to participate in the European Platform for Regulatory Science Research
Human medicines European public assessment report (EPAR): Signifor, pasireotide, Date of authorisation: 24/04/2012, Revision: 16, Status: Authorised
Human medicines European public assessment report (EPAR): Wilzin, zinc, Date of authorisation: 12/10/2004, Revision: 12, Status: Authorised