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: 1 Aug 2014
Categories: Clinical efficacy and safety | Cardiovascular system | Lipid disorders
Access this international scientific guideline
TGA annotations
In place of: EMEA/CHMP/EWP/350495/2009 Concept paper (provided for information 26 March 2010)
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.