Dronedarone product-specific bioequivalence guidance - Scientific guideline

This document provides product-specific guidance on the demonstration of the dronedarone.

Keywords: Bioequivalence, generics, dronedarone

Abbreviations:

• BCS Classification: Biopharmaceutics Classification System
• AUC_0-t: area under the plasma concentration curve from administration to last observed concentration at time t
• AUC_0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
• C_max: maximum plasma concentration

Revision 1

Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/151695/2025 Rev. 1

Document history

Draft dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - Revision 1

Draft: consultation closed Consultation dates: 10/07/2025 to 31/10/2025 Reference Number: EMA/151695/2025 Rev. 1

Draft dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - First version

Draft: consultation closed Consultation dates: 28/07/2017 to 31/10/2017 Reference Number: EMA/CHMP/356875/2017 Summary:

This document provides product-specific guidance on the demonstration of the bioequivalence of dronedarone film-coated tablets

Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - First version

Adopted Reference Number: EMA/CHMP/356875/2017 Legal effective date: 01/08/2018 Summary:

This guidance provides product-specific guidance on the demonstration of the dronedarone.