Rilpivirine product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, rilpivirine

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

Rilpivirine film-coated tablets 25 mg product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/188380/2025/Rev. 1 Legal effective date: 01/01/2026

Document history

Rilpivirine film-coated tablets 25 mg product-specific bioequivalence guidance - First version

Adopted Reference Number: EMA/CHMP/356878/2017 Legal effective date: 01/08/2018 Summary:

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

Overview of comments received on ‘Rilpivirine film-coated tablets 25 mg product-specific bioequivalence guidance’ (EMA/CHMP/356878/2017) - First version

Reference Number: EMA/CHMP/730771/2017

Draft rilpivirine film-coated tablets 25 mg product-specific bioequivalence guidance - First version

Draft: consultation closed Consultation dates: 28/07/2017 to 31/10/2017 Reference Number: EMA/CHMP/356878/2017 Summary:

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