Memantine product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, memantine

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

Memantine film-coated tablets 5, 10, 15 and 20 mg, oral solution 5 mg product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/123562/2025 Rev.1 Legal effective date: 01/11/2025

Document history - First version

Memantine film-coated tablets 5, 10, 15 and 20 mg, oral solution 5 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/315243/2014 Legal effective date: 01/10/2015 Summary:

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

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

Reference Number: EMA/CHMP/116526/2014

Draft memantine product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 15/11/2013 to 15/02/2014 Reference Number: CHMP/PKWP/EMA/423734/2013 Summary:

Memantine product-specific bioequivalence guidance