List of signals discussed at PRAC since September 2012

PRAC recommendations on signals adopted at the 2-5 June 2025 PRAC meeting

Requesting scientific advice or protocol assistance from EMA

Human medicines European public assessment report (EPAR): Vyjuvek, beremagene geperpavec, Date of authorisation: 23/04/2025, Revision: 1, Status: Authorised

Annual activity report 2024

Human medicines European public assessment report (EPAR): Avamys, fluticasone furoate, Date of authorisation: 11/01/2008, Revision: 25, Status: Authorised

Withdrawn application: Lutathera, 09/05/2025

Human medicines European public assessment report (EPAR): Tresiba, insulin degludec, Date of authorisation: 20/01/2013, Revision: 19, Status: Authorised

Human medicines European public assessment report (EPAR): Zoonotic Influenza Vaccine Seqirus, zoonotic influenza vaccine (H5N8) (surface antigen, inactivated, adjuvanted), Date of authorisation: 09/10/2023, Revision: 3, Status: Authorised

Second EMA and European Society of Cardiology (ESC) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 22 May 2025, 15:00 (CEST) to 22 May 2025, 17:00 (CEST)