Draft dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance

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Document details

Download document Draft dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance
Reference number EMA/CHMP/421315/2017
Status draft: consultation open
First published 2017-08-03
Last updated 2017-08-03
Consultation start date 2017-08-03
Consultation end date 2017-10-31
Email address for submissions pkwpsecretariat@ema.europa.eu

Summary

This document provides product-specific guidance on the demonstration of the bioequivalence of dimethyl fumarate