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About this guideline
Overseas effective date: 1 Aug 2014
Categories: Clinical efficacy and safety | Cardiovascular system | Pulmonary arterial hypertension
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TGA annotations
In place of: EMEA/CHMP/EWP/644261/2008 concept paper on this topic (provided for information 1 May 2009)
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.