Apixaban product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of apixaban film-coated tablet 2.5 and 5 mg.

Keywords: Bioequivalence, generics, apixaban

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

Apixaban film-coated tablet 2.5 and 5 mg product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/151689/2025 Rev. 1 Legal effective date: 01/12/2025

Document history

Apixaban film-coated tablet 2.5 and 5 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/291499/2018 Legal effective date: 01/02/2020

Overview of comments received on 'Apixaban film-coated tablet 2.5 and 5 mg product-specific bioequivalence guidance' (EMA/CHMP/291499/2018)

Reference Number: EMA/CHMP/681387/2018

Draft apixaban film-coated tablet 2.5 and 5 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 27/06/2018 to 30/09/2018 Reference Number: EMA/CHMP/291499/2018