Standard operating procedure for renewal of micro-, small- or medium-sized-enterprise status

Standard operating procedure for assignment of micro-, small- or medium-sized-enterprise status

Human medicines European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Sun, sitagliptin,metformin hydrochloride, Date of authorisation: 31/03/2023, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Elebrato Ellipta, fluticasone furoate,umeclidinium,vilanterol, Date of authorisation: 15/11/2017, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): Posaconazole Accord, posaconazole, Date of authorisation: 25/07/2019, Revision: 12, Status: Authorised

UPD registration guide for UI and API users

Human medicines European public assessment report (EPAR): Imatinib Accord, imatinib, Date of authorisation: 30/06/2013, Revision: 25, Status: Authorised

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – April 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 1 April 2025, 10:00 (CEST) to 1 April 2025, 12:00 (CEST)

Minutes - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (April 2025)

Human medicines European public assessment report (EPAR): Arsenic trioxide Mylan, arsenic trioxide, Date of authorisation: 01/04/2020, Revision: 6, Status: Withdrawn