Dabigatran etexilate product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of dabigatran etexilate. 

This document should be read in conjunction with the questions and answers on product-specific bioequivalence, point 4.12.

Keywords: Bioequivalence, generics, dabigatran etexilate

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

Dabigatran etexilate hard capsule 75 mg, 110 mg and 150 mg product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/151692/2025 Rev. 1 Legal effective date: 01/12/2025

Document history

Dabigatran etexilate hard capsule 75 mg, 110 mg and 150 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/805498/2016 Legal effective date: 01/12/2018

Overview of comments received on 'Dabigatran etexilate, hard capsules, 75 mg, 110 mg and 150 mg product-specific bioequivalence guidance'

Reference Number: EMA/CHMP/258276/2017

Draft dabigatran etexilate, hard capsules, 75 mg, 110 mg and 150 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 22/12/2016 to 31/03/2017 Reference Number: EMA/CHMP/805498/2016 Summary:

This document provides product-specific guidance on the demonstration of the bioequivalence of dabigatran