Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance (Draft)

We have adopted this International Scientific Guideline - EMA/CHMP/257298/2018

Last updated

15 January 2025

About this guideline

Adopted by the TGA: 15 July 2019

End of consultation (overseas): 30 September 2018

Categories: Clinical pharmacology and pharmacokinetics | Product-specific bioequivalence

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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