Question and answer on expression / declaration of potency in quantitative and qualitative composition for vancomycin products

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Document details

Download document Question and answer on expression / declaration of potency in quantitative and qualitative composition for vancomycin products
Reference number EMA/CHMP/QWP/128067/2014
Status draft: consultation open
First published 04/03/2014
Last updated 04/03/2014
Consultation start date 04/03/2014
Consultation end date 04/06/2014
Email address for submissions qwp@ema.europa.eu

Summary

This document includes a draft answer to the question 'For vancomycin drug products, what should be declared in terms of potency in the quantitative and qualitative details of the product literature?'