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

Human medicines European public assessment report (EPAR): Onpattro, patisiran, Date of authorisation: 27/08/2018, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR): Fruzaqla, fruquintinib, Date of authorisation: 20/06/2024, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR): Mounjaro, tirzepatide, Date of authorisation: 15/09/2022, Revision: 22, Status: Authorised

Human medicines European public assessment report (EPAR): Litfulo, ritlecitinib, Date of authorisation: 15/09/2023, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Wegovy, semaglutide, Date of authorisation: 06/01/2022, Revision: 19, Status: Authorised

Human medicines European public assessment report (EPAR): Entecavir Viatris (previously Entecavir Mylan), entecavir, Date of authorisation: 18/09/2017, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): Elahere, mirvetuximab soravtansine, Date of authorisation: 14/11/2024, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Osenvelt, denosumab, Date of authorisation: 14/02/2025, Revision: 6, Status: Authorised

Report on the International Active Pharmaceutical Ingredient Inspection Programme 2017 – 2024