International scientific guideline: Paediatric addendum to the CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension

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.