Agomelatine product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of agomelatine oral tablet 25 mg.

Keywords: Bioequivalence, generics, agomelatine

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 effective version

Agomelatine tablet 25 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/800802/2017 Summary:

Agomelatine tablet 25 mg product-specific bioequivalence guidance

Document history

Draft agomelatine oral tablet 25 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 31/01/2018 to 30/04/2018 Reference Number: EMA/CHMP/800802/2017 Summary:

Agomelatine oral tablet 25 mg product-specific bioequivalence guidance