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About this guideline
Adopted by the TGA: 13 March 2025
Overseas effective date: 25 July 2019
Replaces: The draft version: Apixaban film-coated tablet 2.5 and 5 mg product - specific bioequivalence guidance (EMA/CHMP/291499/2018) (Adopted by the TGA 15 July 2019)
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.
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For more information see International scientific guidelines adopted in Australia.