Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

We have adopted this International Scientific Guideline - EMA/CHMP/35552/2019.

Last updated

3 June 2024

About this guideline

Adopted by the TGA: 08 June 2023

Overseas effective date: 1 April 2020

Categories: Clinical pharmacology and pharmacokinetics | Product-specific bioequivalence guidance

TGA annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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