Human medicines European public assessment report (EPAR): Roteas, edoxaban, Date of authorisation: 19/04/2017, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR): Lixiana, edoxaban, Date of authorisation: 19/06/2015, Revision: 22, Status: Authorised

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)

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): Tepmetko, tepotinib, Date of authorisation: 16/02/2022, Revision: 4, Status: Authorised

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