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Guideline on clinical investigation of medicinal products in the treatment of lipid disorders

We have adopted this International Scientific Guideline - EMA/CHMP/748108/2013, Rev. 3.

Last updated

About this guideline

Overseas effective date:  1 January 2017

Replaces: EMA/CHMP/748108/2013 Guideline on clinical investigation of medicinal products in the treatment of lipid disorder (Adopted by TGA 1 August 2014)

Note: To be read in conjunction with the Paediatric addendum to CHMP guideline on clinical investigation of medicinal products in the treatment of lipid disorders (EMA/CHMP/494506/2012 (EMEA/CHMP/EWP/213057/2010)

Categories: Clinical efficacy and safety | Cardiovascular system | Lipid disorders

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.

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