Apixaban film-coated tablet 2.5 and 5 mg product - specific bioequivalence guidance

(Draft)

We have adopted this International Scientific Guideline - EMA/CHMP/291499/2018.

Last updated

3 June 2024

About this guideline

Adopted by the TGA: 15 July 2019

End of consultation (overseas): 30 September 2018

Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics | Product-specific bioequivalence

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.
All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.