Orphan designation: diazoxide choline Treatment of glycogen storage disease type I, 13/12/2024 Positive

Information on the Member States requirement for the nomination of a pharmacovigilance (PhV) contact person at national level

Orphan designation: 4-(4-(2-(Diethylamino)ethoxy)phenyl)-1-(4-methoxybenzyl)-1H-1,2,3-triazol-5-amine Treatment of neurofibromatosis type 2, 13/12/2024 Positive

Orphan designation: divesiran Treatment of polycythaemia vera, 13/12/2024 Positive

Instrument for Pre-accession Assistance (IPA) EMA training on veterinary aspects of AMR and the One Health approach, European Medicines Agency, Amsterdam, the Netherlands, 21 October 2024

Instrument for Pre-accession Assistance (IPA) advanced EMA training on Clinical Trials, Pharmacovigilance and Shortages , European Medicines Agency, Amsterdam, the Netherlands, from 16 November 2023 to 17 November 2023

Instrument for Pre-accession Assistance (IPA) advanced EMA training on Quality and Inspections, European Medicines Agency, Amsterdam, the Netherlands, from 15 June 2023 to 16 June 2023

HMA/EMA multi-stakeholder workshop on artificial intelligence (AI) - enabling the safe and responsible use of AI, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 5 November 2024, 09:00 (CET) to 5 November 2024, 17:40 (CET)

Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group

Minutes of the PRAC meeting 28-31 October 2024