Deferasirox product-specific bioequivalence guidance

Eighth EMA-Medicines for Europe bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, from 9 September 2025, 15:00 (CEST) to 9 September 2025, 17:00 (CEST)

Human medicines European public assessment report (EPAR): Jivi, damoctocog alfa pegol, Date of authorisation: 22/11/2018, Revision: 7, Status: Authorised

PSUSA/00001789/202411

Human medicines European public assessment report (EPAR): Amvuttra, vutrisiran, Date of authorisation: 15/09/2022, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Apixaban Accord, apixaban, Date of authorisation: 23/07/2020, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Breyanzi, lisocabtagene maraleucel, Date of authorisation: 04/04/2022, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR): Veklury, remdesivir, Date of authorisation: 03/07/2020, Revision: 30, Status: Authorised

Human medicines European public assessment report (EPAR): Kovaltry, octocog alfa, Date of authorisation: 18/02/2016, Revision: 14, Status: Authorised

Human medicines European public assessment report (EPAR): Exparel liposomal, bupivacaine, Date of authorisation: 16/11/2020, Revision: 2, Status: Authorised