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Guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome

We have adopted this International Scientific Guideline - EMA/CHMP/760125/2016. 

Last updated

About this guideline

Adopted by the TGA: 28 February 2020

Overseas effective date: 1 March 2018

Replaces: CPMP/EWP/570/98 - Points to consider on the clinical investigation of new medicinal products for the treatment of acute coronary syndrome (ACS) without persistent ST segment elevation and CPMP/EWP/967/01 - Points to Consider on the Clinical Development of Fibrinolytic Medicinal Products in the Treatment of Patients with St Segment Elevation Acute Myocardial Infarction (STEMI)

Categories: Clinical efficacy and safety | Cardiovascular system | Coronary artery disease 

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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