Standard operating procedure for annual review of VeDDRA list to be used in EudraVigilance Veterinary

Human medicines European public assessment report (EPAR): Conexxence, denosumab, Date of authorisation: 18/07/2025, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Kisunla, donanemab, Date of authorisation: 24/09/2025, Revision: 3, Status: Authorised

New product information wording – Extracts from PRAC recommendations on signals adopted at the 28-31 October 2024 PRAC

Human medicines European public assessment report (EPAR): Revolade, eltrombopag, Date of authorisation: 11/03/2010, Revision: 39, Status: Authorised

Human medicines European public assessment report (EPAR): Vydura, rimegepant, Date of authorisation: 25/04/2022, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): Yesafili, aflibercept, Date of authorisation: 15/09/2023, Revision: 8, Status: Authorised

EMA/PE/0000226657

Opinion/decision on a Paediatric investigation plan (PIP): Rizmoic, naldemedine tosilate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastrointestinal disorders, PIP number: EMA/PE/0000226303

EMEA-003395-PIP02-23