Oseltamivir product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, oseltamivir

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

Oseltamivir hard capsules 30, 45 and 75 mg, powder for oral suspension 6 mg/ml and 12 mg/ml product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/151698/2025 Rev. 1 Legal effective date: 01/12/2025

Document history

Oseltamivir hard capsules 30, 45 and 75 mg, powder for oral suspension 6 mg/ml and 12 mg/ml product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/315246/2014 Legal effective date: 01/10/2015 Summary:

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

Overview of comments received on 'Draft oseltamivir product-specific bioequivalence guidance'

Reference Number: EMA/CHMP/116544/2014

Draft oseltamivir product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 15/11/2013 to 15/02/2014 Reference Number: CHMP/PKWP/EMA/423665/2013 Summary:

Oseltamivir product-specific bioequivalence guidance