Agenda - Public webinar on pack size submissions: from XEVMPD to product management service (PMS)
Product Management Service (PMS) Application Programming Interface (API) training session, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 July 2024, 14:00 (CEST) to 8 July 2024, 15:30 (CEST)
Core summary of product characteristics for human plasma-derived and recombinant coagulation factor IX products - Scientific guideline
Human medicines European public assessment report (EPAR): Mepsevii, vestronidase alfa, Date of authorisation: 23/08/2018, Revision: 8, Status: Authorised
Summary of opinion: Cresemba, 27/06/2024 Positive
Clinical investigation of recombinant and human plasma-derived factor IX products - Scientific guideline
Mandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP)
Clinical Trial Information System (CTIS) - Sponsor handbook
Paediatric investigation plan (PIP) - Key elements guidance
CTIS newsflash - 28 June 2024