Qualification of novel methodologies for medicinal product development: guidance to applicants
Qualification of novel methodologies for medicinal product development: guidance to applicants
Qualification of novel methodologies for medicinal product development: guidance to applicants
Human medicines European public assessment report (EPAR): Tysabri, natalizumab, Date of authorisation: 27/06/2006, Revision: 53, Status: Authorised
Agenda of the PRAC meeting 6-9 July 2026
Agenda of the HMPC meeting 6-8 July 2026
List of signals discussed at PRAC since September 2012
Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (22 May 2026 - 25 June 2026)
Start of procedure: Extension of marketing authorisation (22 May 2026 - 25 June 2026)
Human medicines European public assessment report (EPAR): Alprolix, eftrenonacog alfa, Date of authorisation: 12/05/2016, Revision: 12, Status: Authorised
Seventeenth Industry Standing Group (ISG) meeting, Online, from 29 June 2026, 09:30 (CEST) to 29 June 2026, 13:10 (CEST)
17th Industry Standing Group (ISG) meeting, Online, from 29 June 2026, 09:30 (CEST) to 29 June 2026, 13:10 (CEST)