Clinical Trials Information System

Human medicines European public assessment report (EPAR): Fabhalta, iptacopan, Date of authorisation: 17/05/2024, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Lytgobi, futibatinib, Date of authorisation: 04/07/2023, Revision: 3, Status: Authorised

Unlocking PMS API potential: Edit functionality training for MAHs, Online, European Medicines Agency, Amsterdam, the Netherlands, from 16 October 2025, 10:00 (CEST) to 16 October 2025, 11:30 (CEST)

EMA roundtable with stakeholders on the 20th anniversary of the SME Regulation, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 17 October 2025, 09:30 (CEST) to 17 October 2025, 14:30 (CEST)

Human medicines European public assessment report (EPAR): Rybrevant, amivantamab, Date of authorisation: 09/12/2021, Revision: 10, Status: Authorised

List of medicinal products under additional monitoring

List of medicinal products under additional monitoring

EU Regulatory System Incident Management Plan for Medicines for Human Use

Business process description for pharmacovigilance