Alectinib product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of alectinib hard capsule 150 mg.
Keywords: Bioequivalence, generics, alectinib
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Alectinib hard capsule 150 mg product-specific bioequivalence guidance (PDF/125.92 KB)
Adopted
First published: 15/10/2019
Legal effective date: 01/04/2020
EMA/CHMP/790261/2018 -
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Overview of comments received on 'Alectinib hard capsule 150 mg product-specific bioequivalence guidance' (PDF/159.07 KB)
First published: 19/12/2019
EMA/CHMP/582874/2019