European Medicines Agency Write PMS API implementation Guide

Human medicines European public assessment report (EPAR): Osenvelt, denosumab, Date of authorisation: 14/02/2025, Revision: 3, Status: Authorised

Applications for new human medicines under evaluation: July 2025

Human medicines European public assessment report (EPAR): Yesafili, aflibercept, Date of authorisation: 15/09/2023, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Fampridine Accord, fampridine, Date of authorisation: 24/09/2020, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Duvyzat, givinostat, Date of authorisation: 06/06/2025, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Aldara, imiquimod, Date of authorisation: 18/09/1998, Revision: 33, Status: Authorised

Regulatory science research needs

Regulatory Science - Research needs - 2025 update

Referral: Quarter-based selective dry cow therapy Article 141(1)(i) Procedure started