Human medicines European public assessment report (EPAR): Kavigale, sipavibart, Date of authorisation: 20/01/2025, Revision: 1, Status: Authorised

List of signals discussed at PRAC since September 2012

Human medicines European public assessment report (EPAR): Deltyba, delamanid, Date of authorisation: 27/04/2014, Date of refusal: 25/07/2013, Revision: 27, Status: Authorised

Human medicines European public assessment report (EPAR): mResvia, single-stranded 5' capped mRNA encoding the respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation, Date of authorisation: 22/08/2024, Revision: 4, Status: Authorised

European Medicines Agency policy on access to EudraVigilance data for medicinal products for human use - Revision 5

CVMP Interested Parties’ meeting May 2025, European Medicines Agency, Amsterdam, the Netherlands, from 14 May 2025, 17:00 (CEST) to 14 May 2025, 19:00 (CEST)

Human medicines European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Viatris (previously Clopidogrel / Acetylsalicylic acid Mylan), clopidogrel,acetylsalicylic acid, Date of authorisation: 09/01/2020, Revision: 9, Status: Authorised

PRAC recommendations on signals adopted at the 7-10 April 2025 meeting

Human medicines European public assessment report (EPAR): Ecansya (previously Capecitabine Krka), capecitabine, Date of authorisation: 20/04/2012, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR): Stoboclo, denosumab, Date of authorisation: 14/02/2025, Revision: 1, Status: Authorised