Compilation of Union procedures on inspections and exchange of information
Compilation of Union procedures on inspections and exchange of information
Compilation of Union procedures on inspections and exchange of information
CTIS newsflash - 15 September 2023
Network Portfolio Roadmap 2023-2025
List of industry subject matter experts and list of planned calls for industry subject matter experts
Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies
Report on the implementation of the EMA-EUnetHTA 21 work plan 2021 - 2023
Recommendation for maintenance of orphan designation at the time of addition of new indications to the marketing authorisation: Votubia (everolimus) for the treatment of tuberous sclerosis
Management Board meeting: 7-8 June 2023, European Medicines Agency, Amsterdam, the Netherlands, from 07/06/2023 to 08/06/2023
Human medicines European public assessment report (EPAR): Pelgraz, pegfilgrastim, Neutropenia, Date of authorisation: 21/09/2018, Revision: 11, Status: Authorised
Orphan designation: N-(5-tert-Butylisoxazol-3-yl)-N'-{4-[7-(2-(morpholin-4-yl)ethoxy) imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea di-hydrochloride salt, Treatment of acute myeloid leukaemia, 23/03/2009, Positive