European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
Guidance on the application of the amended Variations Regulation from 1 January 2025
Agenda - PDCO agenda of the 25-28 March 2025 meeting
Webinar on reflection paper on the qualification of non-mutagenic impurities, Online, European Medicines Agency, Amsterdam, the Netherlands, from 6 March 2025, 13:00 (CET) to 6 March 2025, 15:30 (CET)
Minutes of the CVMP meeting 11-12 February 2025
EMEA-002796-PIP01-20-M02
EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 October 2025, 10:00 (CEST) to 9 October 2025, 16:10 (CEST)
EMEA-002744-PIP01-19-M01
Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0038/2024