Rivaroxaban product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of rivaroxaban. Please note that no comments have been received for this guideline during the public consultation period.

Keywords: Bioequivalence, generics, rivaroxaban

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

Current version - effective 1 January 2026

Rivaroxaban film-coated tablets 2.5, 10, 15 and 20mg product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/188384/2025/Rev. 1 Legal effective date: 01/01/2026

Document history

Rivaroxaban film-coated tablets 2.5, 10, 15 and 20mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/160650/2016 Legal effective date: 01/11/2016 Summary:

This document provides product-specific guidance on demonstration of bioequivalence of rivaroxaban

Draft rivaroxaban film-coated tablets 2.5, 10, 15 and 20mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 01/10/2015 to 01/01/2016 Reference Number: EMA/CHMP/PKWP/151340/2015 Summary:

The European Medicines Agency has decided to routinely publish product-specific bioequivalence guidance for a more consistent approach to the assessment of marketing authorisation applications for generic medicines across all authorisation routes available in the European Union. This guidance document describes the specific requirements for the demonstration of bioequivalence for rivaroxaban.