Draft prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance - Revision 1

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Document details

Download document Draft prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance - Revision 1
Reference number EMA/CHMP/158772/2016/Rev. 1
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 prasugrel.