PSUSA/00002076/202506

PSUSA/00000812/202506

PSUSA/00002639/202507

Q&A clinic on Substance, Organisation, Referentials Management Services - March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 10 March 2026, 11:00 (CET) to 10 March 2026, 12:00 (CET)

Guidance for applicants for the preparation of the precise scope section of the variation application form

Human medicines European public assessment report (EPAR): Infanrix Hexa, diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed), Date of authorisation: 23/10/2000, Revision: 49, Status: Authorised

Human medicines European public assessment report (EPAR): Retsevmo, selpercatinib, Date of authorisation: 11/02/2021, Revision: 20, Status: Authorised

Human medicines European public assessment report (EPAR): Adrovance, alendronic acid,colecalciferol, Date of authorisation: 04/01/2007, Revision: 29, Status: Authorised

PSUSA/00001516/202506

PSUSA/00010291/202506