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About this guideline
Overseas effective date: 5 June 2012
Replaces: EMEA/CHMP/EWP/644261/2008 concept paper on this topic (provided for information 1 May 2009)
Note: This document is a paediatric addendum to the Guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension (EMEA/CHMP/EWP/356954/2008).It includes guidance on paediatric clinical medicine development, with highlights on differences from adult pulmonary arterial hypertension and points out paediatric specific issues.
Categories: Clinical efficacy and safety | Cardiovascular system | Pulmonary arterial hypertension
TGA annotations: Nil
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For more information see International scientific guidelines adopted in Australia.