Ticagrelor product-specific bioequivalence guidance

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

Keywords: This document provides product-specific guidance on the demonstration of the bioequivalence of ticagrelor.

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

Ticagrelor film-coated tablets 60 mg and 90 mg productspecific bioequivalence guidance - Revision 1

AdoptedReference Number: EMA/188392/2025/Rev. 1Legal effective date: 01/01/2026

Document history

Ticagrelor film-coated tablets 90mg product-specific bioequivalence guidance

AdoptedReference Number: EMA/CHMP/177281/2016Legal effective date: 01/11/2016Summary:

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

Overview of comments on ‘Ticagrelor film-coated tablets 90mg product specific bioequivalence guidance’

Reference Number: EMA/CHMP/206139/2016Summary:

Overview of comments on ‘Ticagrelor film-coated tablets 90mg product specific bioequivalence guidance’ (EMA/CHMP/PKWP/151478/2015)

Draft ticagrelor film-coated tablets 90mg product-specific bioequivalence guidance

Draft: consultation closedConsultation dates: 01/10/2015 to 01/01/2016Reference Number: EMA/CHMP/PKWP/151478/2015Summary:

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 ticagrelor.