PSUSA/00001635/202602
PSUSA/00001635/202602
PSUSA/00001635/202602
List of industry subject matter experts and list of planned calls for industry subject matter experts
PSUSA/00001099/202603
Human medicines European public assessment report (EPAR): Oxlumo, lumasiran, Date of authorisation: 19/11/2020, Revision: 7, Status: Authorised
Oslif Breezhaler : EPAR - All Authorised presentations
Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 19, Status: Authorised
Human medicines European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron), dinutuximab beta, Date of authorisation: 08/05/2017, Revision: 19, Status: Authorised
Human medicines European public assessment report (EPAR): Opdivo, nivolumab, Date of authorisation: 19/06/2015, Revision: 77, Status: Authorised
Human medicines European public assessment report (EPAR): Jubereq, denosumab, Date of authorisation: 26/05/2025, Revision: 2, Status: Authorised
Stakeholder Meeting on the transferable data exclusivity voucher (TDEV) for priority antimicrobials, Online, Broadcast, from 12 November 2026, 14:00 (CET) to 12 November 2026, 17:00 (CET)