Agenda - DARWIN EU Advisory Board - 25 November 2024
Agenda - DARWIN EU Advisory Board - 25 November 2024
Agenda - DARWIN EU Advisory Board - 25 November 2024
Regulatory Procedure Management in IRIS roadmap
Type-IB variations: questions and answers
Type-IA variations: questions and answers
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
Expected publication dates of PRAC recommendations on safety signals
Human medicines European public assessment report (EPAR): Hympavzi, marstacimab, Date of authorisation: 18/11/2024, Revision: 2, Status: Authorised
Withdrawn application: Vectra 3D, 27/11/2024
Human medicines European public assessment report (EPAR): Hydrocortisone Aguettant, Status: Application withdrawn