Trametinib product-specific bioequivalence guideline

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

AdoptedReference Number: EMA/41624/2023Legal effective date: 01/06/2025

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

Reference Number: EMA/339228/2024

Document history

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

Draft: consultation closedConsultation dates: 11/03/2024 to 30/06/2024Reference Number: EMA/CHMP/41624/2023Summary:

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