Dimethyl fumarate product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of dimethyl fumarate.
Keywords: Bioequivalence, generics, dimethyl fumarate
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Dimethyl fumarate gastro-resistant capsule 120 mg and 240 mg product-specific bioequivalence guidance (PDF/81.56 KB)
Adopted
First published: 26/06/2018
Last updated: 26/06/2018
Legal effective date: 01/12/2018
EMA/CHMP/421315/2017 -
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Overview of comments received on draft dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance (PDF/155.9 KB)
Adopted
First published: 04/12/2018
EMA/CHMP/730229/2017 -
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Draft dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance (PDF/75.74 KB)
Draft: consultation closed
First published: 03/08/2017
Last updated: 03/08/2017
Consultation dates: 03/08/2017 to 31/10/2017
EMA/CHMP/421315/2017
