Emtricitabine / rilpivirine / tenofovir disoproxil product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of emtricitabine, rilpivirine, tenofovir disoproxil.

Keywords: Bioequivalence, generics, emtricitabine, rilpivirine, tenofovir disoproxil

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

Emtricitabine/rilpivirine/tenofovir disoproxil film-coated tablets 200 mg/25 mg/245 mg product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/188363/2025 Rev. 1 Legal effective date: 01/01/2026

Document history

Emtricitabine/rilpivirine/tenofovir disoproxil film-coated tablets 200 mg/25 mg/245 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/805532/2016 Legal effective date: 01/01/2018

Draft emtricitabine/rilpivirine/tenofovir disoproxil, film-coated tablets, 200 mg/25 mg/245 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 22/12/2016 to 31/03/2017 Reference Number: EMA/CHMP/805532/2016 Summary:

This document provides product-specific guidance on the demonstration of the bioequivalence of emtricitabine, rilpivirine, tenofovir and disoproxil.