Human medicines European public assessment report (EPAR): Aclasta, zoledronic acid, Date of authorisation: 15/04/2005, Revision: 36, Status: Authorised

Submission dates

Respiratory syncytial virus (RSV)

Human medicines European public assessment report (EPAR): Dupixent, dupilumab, Date of authorisation: 26/09/2017, Revision: 48, Status: Authorised

Validation checklist for initial marketing authorisation applications - biologicals other than immunologicals (applicable to submissions under Regulation (EU) 2019/6)

Focus group on submission predictability: 2025 final report

Herbal medicinal product: Rusci rhizoma, Ruscus aculeatus L., C: ongoing call for scientific data

Human medicines European public assessment report (EPAR): Micardis, telmisartan, Date of authorisation: 16/12/1998, Revision: 31, Status: Authorised

Human medicines European public assessment report (EPAR): Tepmetko, tepotinib, Date of authorisation: 16/02/2022, Revision: 4, Status: Authorised

Summary of opinion: Startvac, 16/04/2026 Positive