Reflection paper on assessment of cardiovascular safety profile of medicinal products

We have adopted this International Scientific Guideline - EMA/CHMP/50549/2015

Last updated

23 December 2024

Overseas effective date: 25 Feburary 2016

Provided for information: January 2017

Categories: Clinical efficacy and safety | Cardiovascular system

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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