Workshop on a tailored clinical approach in biosimilar development, Online, European Medicines Agency, Amsterdam, the Netherlands, from 22 September 2025, 09:00 (CEST) to 22 September 2025, 15:00 (CEST)

Medicine shortage communication (MSC): Zypadhera (olanzapine pamoate monohydrate powder and solvent for prolonged release suspension for injection)

Agenda - Multi-stakeholder workshop on tailored clinical approach for biosimilars

Ketoprofen: European public maximum-residue-limit assessment report (EPMAR) - CVMP

Human medicines European public assessment report (EPAR): Abecma, idecabtagene vicleucel, Date of authorisation: 18/08/2021, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): Zebinix, eslicarbazepine acetate, Date of authorisation: 21/04/2009, Revision: 33, Status: Authorised

Human medicines European public assessment report (EPAR): Enurev Breezhaler, glycopyrronium bromide, Date of authorisation: 28/09/2012, Revision: 11, Status: Authorised

Human medicines European public assessment report (EPAR): Adempas, riociguat, Date of authorisation: 27/03/2014, Revision: 17, Status: Authorised

Quality guidelines

Feedback from European Medicine Agency (EMA) to the EU Commission request to evaluate the feasibility of alternatives to replace titanium dioxide (TiO2) in medicinal products and its possible impact on medicines’ availability