Orphan designation: autologous CD4+ and CD8+ T cells transduced with a lentiviral vector encoding an affinity enhanced T cell receptor specific to MAGE-A4 Treatment of soft tissue sarcoma, 04/06/2020 Positive

Human medicines European public assessment report (EPAR): SomaKit TOC, edotreotide, Date of authorisation: 08/12/2016, Revision: 23, Status: Authorised

United for health at WorldPride 2026

Human medicines European public assessment report (EPAR): Orserdu, elacestrant, Date of authorisation: 15/09/2023, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Vitrakvi, larotrectinib, Date of authorisation: 19/09/2019, Revision: 19, Status: Authorised

Human medicines European public assessment report (EPAR): Skyclarys, omaveloxolone, Date of authorisation: 09/02/2024, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR): Spinraza, nusinersen, Date of authorisation: 30/05/2017, Revision: 21, Status: Authorised

PSUSA/00003186/202511

List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment

Retinal stimulation systems - Notified Body 0344 - 12/06/2026 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)