Memantine product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of memantine.
Keywords: Bioequivalence, generics, memantine
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
-
List item
Memantine film-coated tablets 5, 10, 15 and 20 mg, oral solution 5 mg product-specific bioequivalence guidance (PDF/78.51 KB)
Adopted
First published: 25/05/2016
Last updated: 25/05/2016
Legal effective date: 01/10/2015
EMA/CHMP/315243/2014 -
List item
Overview of comments received on 'Draft memantine product-specific bioequivalence guidance' (PDF/115.96 KB)
First published: 10/04/2015
Last updated: 10/04/2015
EMA/CHMP/116526/2014 -
List item
Draft memantine product-specific bioequivalence guidance (PDF/80.34 KB)
Draft: consultation closed
First published: 15/11/2013
Last updated: 15/11/2013
Consultation dates: 15/11/2013 to 15/02/2014
CHMP/PKWP/EMA/423734/2013