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Dabigatran etexilate product-specific bioequivalence guidance
Human medicines European public assessment report (EPAR): Levetiracetam ratiopharm, levetiracetam, Date of authorisation: 26/08/2011, Revision: 16, Status: Authorised
Annual activity report 2024
Real-world evidence
Memantine product-specific bioequivalence guidance
Orphan designation: Induced pluripotent stem cells-derived myogenic progenitor cells Treatment of Becker muscular dystrophy, 22/05/2025 Positive
Posaconazole product-specific bioequivalence guidance
Infosheet: EMA review of real-world data studies from September 2021 to February 2025
Real-world evidence framework to support EU regulatory decision-making: 3rd report on the experience gained with regulator-led studies from February 2024 to February 2025