Referral: Sodium oxybate-containing syrup and oral solution for alcohol dependence, sodium oxybate Article 31 referrals Under evaluation, 28/10/2025

Human medicines European public assessment report (EPAR): Keppra, levetiracetam, Date of authorisation: 29/09/2000, Revision: 57, Status: Authorised

Agenda of the PRAC meeting 27 - 30 October 2025

EMEA-002712-PIP01-19-M01

EMEA-002287-PIP01-17-M03

Human medicines European public assessment report (EPAR): Fanskya, Mozafancogene autotemcel, Status: Application withdrawn

Human medicines European public assessment report (EPAR): Lemtrada, alemtuzumab, Date of authorisation: 12/09/2013, Revision: 27, Status: Authorised

PSUSA/00010631/202412

Human medicines European public assessment report (EPAR): Adtralza, tralokinumab, Date of authorisation: 17/06/2021, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): Elzonris, tagraxofusp, Date of authorisation: 07/01/2021, Revision: 8, Status: Authorised