Vortioxetine hydrobromide / vortioxetine lactate product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of vortioxetine.
Keywords: Bioequivalence, generics, vortioxetine
Abbreviations:
- BCS Classification: Biopharmaceutics Classification System
- AUC0-t: area under the plasma concentration curve from administration to last observed concentration at time t
- AUC0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
- Cmax: maximum plasma concentration
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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' (PDF/102.11 KB)
First published: 10/07/2017
Last updated: 10/07/2017
EMA/CHMP/260596/2017 -
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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 (PDF/130.41 KB)
Draft: consultation closed
First published: 22/12/2016
Last updated: 22/12/2016
Consultation dates: 22/12/2016 to 31/03/2017
EMA/CHMP/474974/2016