Vortioxetine hydrobromide / vortioxetine lactate product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, vortioxetine

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

Vortioxetine hydrobromide immediate release tablets 5 mg, 10 mg, 15 mg, and 20 mg; vortioxetine lactate oral drops solution 20 mg/ml product-specific bioequivalence - Revision 1

Adopted Reference Number: EMA/188396/2025/Rev. 1 Legal effective date: 01/01/2026

Document history

Vortioxetine hydrobromide immediate release tablets 5 mg, 10 mg, 15 mg, and 20 mg; vortioxetine lactate oral drops solution 20 mg/ml product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/474974/2016 Legal effective date: 01/01/2018

Overview of comments on 'Vortioxetine hydrobromide immediate release tablets 5 mg, 10 mg, 15 mg, and 20 mg; vortioxetine lactate oral drops solution 20 mg/ml product-specific bioequivalence guidance'

Reference Number: EMA/CHMP/260596/2017

Draft vortioxetine hydrobromide, 5 mg, 10 mg, 15 mg and 20 mg immediate release tablets, vortioxetine lactate, oral drops solution 20 mg/ml product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 22/12/2016 to 31/03/2017 Reference Number: EMA/CHMP/474974/2016 Summary:

This document provides product-specific guidance on the demonstration of the bioequivalence of vortioxetine hydrobromide and vortioxetine lactate.