Trametinib product-specific bioequivalence guideline

HumanScientific guidelines

French is available via eTranslation, the European Commission's machine translation service.

Translate to French | Important information about machine translation

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:

English (EN) (126.39 Ko - PDF)

Première publication:
Voir

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

Reference Number: EMA/339228/2024

English (EN) (332.94 Ko - PDF)

Première publication:
Voir

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 Ko - PDF)

Première publication:
Voir

Share this page