Human medicines European public assessment report (EPAR): Bimzelx, bimekizumab, Psoriasis, Date of authorisation: 20/08/2021, Revision: 5, Status: Authorised

Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) AI workshop – Smart regulation in a rapidly evolving world, European Medicines Agency, Amsterdam, the Netherlands, from 20/11/2023 to 21/11/2023

Human medicines European public assessment report (EPAR): Livmarli, Maralixibat chloride, Alagille Syndrome, Date of authorisation: 09/12/2022, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Moventig, naloxegol, Constipation;Opioid-Related Disorders, Date of authorisation: 07/12/2014, Revision: 15, Status: Authorised

Type-IA variations: questions and answers

Worksharing: questions and answers

Pre-authorisation guidance

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure