Asenapine product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, asenapine

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 - Revision 1

Asenapine sublingual tablets 5 and 10 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/151690/2025 Rev. 1 Legal effective date: 01/11/2016

Document history

Asenapine sublingual tablets 5 and 10 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/158542/2016 Legal effective date: 01/11/2016 Summary:

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

Overview of comments on 'Asenapine sublingual tablets 5 and 10 mg product-specific bioequivalence guidance'

Reference Number: EMA/CHMP/162825/2016 Summary:

Asenapine sublingual tablets 5 and 10 mg product-specific bioequivalence guidance

Draft asenapine sublingual tablets 5 and 10 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 15/07/2015 to 01/11/2015 Reference Number: EMA/CHMP/PKWP/269533/2015 Summary:

The European Medicines Agency has decided to routinely publish product-specific bioequivalence guidance for a more consistent approach to the assessment of marketing authorisation applications for generic medicines across all authorisation routes available in the European Union. This guidance document describes the specific requirements for the demonstration of bioequivalence for asenapine sublingual.