Trametinib product-specific bioequivalence guideline

HumanScientific guidelines

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This document provides product-specific guidance on the demonstration of the bioequivalence of trametinib.

Keywords: Bioequivalence, generics, trametinib

Current version

Trametinib film-coated tablet 0.5 and 2mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/41624/2023 Legal effective date:

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Overview of comments received on Trametinib film-coated tablet 0.5 and 2mg product-specific bioequivalence guidance

Reference Number: EMA/339228/2024

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Document history

Trametinib film-coated tablet 0.5 and 2mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: to Reference Number: EMA/CHMP/41624/2023 Summary:

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

English (EN) (136.78 KB - PDF)

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