Regulatory Perspectives on Herbal Medicinal Botanical Drug Product Development - Joint FDA-EMA Workshop: Event agenda

List of medicinal products under additional monitoring

List of medicinal products under additional monitoring

List of medicines under additional monitoring

List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)

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

Human medicines European public assessment report (EPAR): Trodelvy, sacituzumab govitecan, Date of authorisation: 22/11/2021, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR): Inflectra, infliximab, Date of authorisation: 10/09/2013, Revision: 35, Status: Withdrawn

Human medicines European public assessment report (EPAR): Macitentan Accord, macitentan, Date of authorisation: 24/09/2025, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Macitentan AccordPharma, macitentan, Date of authorisation: 24/09/2025, Revision: 1, Status: Authorised