Aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance

(Draft)

We have adopted this International Scientific Guideline - EMA/CHMP/291450/2018.

Last updated

3 June 2024

About this guideline

Adopted by the TGA: 15 Jul 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.
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