Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October

Human medicines European public assessment report (EPAR): Itvisma, onasemnogene abeparvovec, Date of authorisation: 30/06/2026, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Bysumlog, insulin lispro, Date of authorisation: 06/05/2026, Revision: 2, Status: Authorised

Opinion on medicine for use outside EU: Ivermectin/Albendazole, ivermectin,albendazole, Parasitic Diseases,Helminthiasis,Hookworm Infections,Ascaridida Infections,Trichuriasis,Strongyloidiasis, 30/01/2025 Positive opinion

Good manufacturing practice: Multistakeholder workshop on expert contributions to artificial intelligence guidance development (Annex 22), Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 June 2026, 09:00 (CEST) to 1 July 2026, 17:00 (CEST)

Human medicines European public assessment report (EPAR): Riltrava Aerosphere, formoterol fumarate dihydrate,glycopyrronium,budesonide, Date of authorisation: 06/01/2022, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR): Ebvallo, tabelecleucel, Date of authorisation: 16/12/2022, Revision: 8, Status: Authorised

External whistleblowing policy

Human medicines European public assessment report (EPAR): Byetta, exenatide, Date of authorisation: 20/11/2006, Revision: 30, Status: Withdrawn

Policy 72: Policy on the handling of information from external persons on breaches related to the authorisation, supervision and maintenance of human and veterinary medicinal products or other EMA activities