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About this guideline
Overseas effective date: November 2005
Note: This should be read together with ICH guideline E14 - the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (R3) – questions and answers (ICH14 Q&As; EMA/CHMP/ICH/310133/2008).
Categories: ICH | Efficacy
Clinical efficacy and safety | Cardiovascular system | Arrythmias
TGA annotations:
QT prolongation would be of regulatory concern if either the estimated QT prolongation was >5ms OR the upper bound of the 95% confidence interval was >10msude 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.
- 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.