Timetable: Annual renewal application of conditional marketing authorisation - ATMP

Human medicines European public assessment report (EPAR): Poherdy, pertuzumab, Date of authorisation: 23/04/2026, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Yesintek, ustekinumab, Date of authorisation: 14/02/2025, Revision: 4, Status: Authorised

List of medicinal products under additional monitoring

List of medicinal products under additional monitoring

NovoNordisk insulin (human insulin) (various short-, rapid-, intermediate-, mixed- and long-acting forms)

Human medicines European public assessment report (EPAR): Cablivi, caplacizumab, Date of authorisation: 30/08/2018, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): Tevimbra, tislelizumab, Date of authorisation: 15/09/2023, Revision: 17, Status: Authorised

Human medicines European public assessment report (EPAR): Otulfi, ustekinumab, Date of authorisation: 25/09/2024, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Rezdiffra, resmetirom, Date of authorisation: 18/08/2025, Revision: 1, Status: Authorised