Fourth European Medicines Agency - Medtech Europe bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 21 November 2025

Highlights – Fourth EMA-Vaccines Europe bilateral meeting

Faecal microbiota transplantation EU-IN Horizon Scanning Report

Human medicines European public assessment report (EPAR): Datopotamab deruxtecan Daiichi Sankyo, datopotamab deruxtecan, Status: Application withdrawn

Human medicines European public assessment report (EPAR): Slenyto, melatonin, Date of authorisation: 20/09/2018, Revision: 14, Status: Authorised

Human medicines European public assessment report (EPAR): Uzpruvo, ustekinumab, Date of authorisation: 05/01/2024, Revision: 8, Status: Authorised

Agenda - PCWP/HCPWP and all eligible organisations meeting 2025

Human medicines European public assessment report (EPAR): Norvir, ritonavir, Date of authorisation: 25/08/1996, Revision: 71, Status: Authorised

Human medicines European public assessment report (EPAR): Roctavian, valoctocogene roxaparvovec, Date of authorisation: 24/08/2022, Revision: 9, Status: Authorised

Medicine shortage communication (MSC) : Beriglobin (human normal immunoglobulin), 2 mL and 5 mL solution for injection in pre-filled syringe: supply shortage and cessation of marketing (discontinuation)