Veterinary medicines European public assessment report (EPAR): Lenivia, izenivetmab, Status: Opinion

Veterinary medicines European public assessment report (EPAR): Vaxxitek HVT+IBD+H5, avian influenza vaccine (live recombinant), Status: Opinion

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 7-9 October 2025

Data protection and privacy at EMA

European Medicines Agency (EMA) and European Respiratory Society (ERS) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 October 2025, 13:00 (CET) to 30 October 2025, 15:00 (CET)

Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 15, Status: Authorised

ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines - Scientific guideline

ICH M14 guideline on general principles on planning, designing, analysing, and reporting of non-interventional studies that utilise real-world data for safety assessment of medicines Step 5

Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products

Veterinary medicines European public assessment report (EPAR): Novem, meloxicam, Status: Authorised