Guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension

We have adopted this International Scientific Guideline - EMEA/CHMP/EWP/356954/2008

Last updated

17 January 2025

About this guideline

Overseas effective date: 1 May 2010

Note: To be read in conjunction with the Paediatric addendum to the CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension (EMA/CHMP/213972/2010).

Categories: Clinical efficacy and safety | Cardiovascular system | Pulmonary arterial hypertension

TGA Annotations: Nil

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.
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