Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
About this guideline
Overseas effective date: 9 Feb 2009
Categories: Clinical efficacy and safety | Cardiovascular system | Arrythmias
Access this international scientific guideline
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 >10ms
For more information see International scientific guidelines adopted in Australia.
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.