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Guideline on clinical investigation of medicinal products for the treatment of acute heart failure

We have adopted this International Scientific Guideline - CPMP/EWP/2986/03 Rev. 1.

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About this guideline

Overseas effective date: 1 December 2015

Replaces: CPMP/EWP/2986/03 Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Cardiac Failure. Addendum on Acute Cardiac Failure (CPMP/EWP/235/95 Rev 1); and EMA/CHMP/EWP/215701/2010 Concept paper on the need for revision of the addendum on acute cardiac failure (CPMP/EWP/2986/03) (provided for information 1 August 2014)

Categories: Clinical efficacy and safety | Cardiovascular system | Heart failure

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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