PMS PUI Training: Product data submission & bulk edit made easy, Online, European Medicines Agency, Amsterdam, the Netherlands, from 6 October 2025, 10:00 (CEST) to 6 October 2025, 12:00 (CEST)

Human medicines European public assessment report (EPAR): Kayfanda, odevixibat, Date of authorisation: 19/09/2024, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Bylvay, odevixibat, Date of authorisation: 16/07/2021, Revision: 11, Status: Authorised

Human medicines European public assessment report (EPAR): Levetiracetam Accord, levetiracetam, Date of authorisation: 03/10/2011, Revision: 20, Status: Authorised

Human medicines European public assessment report (EPAR): Imfinzi, durvalumab, Date of authorisation: 21/09/2018, Revision: 26, Status: Authorised

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7 – 10 July 2025

Ixchiq: temporary restriction on vaccinating people 65 years and older to be lifted

Human medicines European public assessment report (EPAR): Filsuvez, birch bark extract, Date of authorisation: 21/06/2022, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Capecitabine Teva, capecitabine, Date of authorisation: 20/04/2012, Revision: 17, Status: Authorised

Sharing data across systems: Master data on human medicines