Clinical investigation of medicinal products for the treatment of pulmonary arterial hypertension - Scientific guideline

This document provides guidance on the evaluation of new medicinal products used in combination in the treatment of pulmonary arterial hypertension.

Keywords: Pulmonary arterial hypertension (PAH), revised WHO classification on pulmonary hypertension

 

Current effective version

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

AdoptedReference Number: EMEA/CHMP/EWP/356954/2008Legal effective date: 01/05/2010

Document history

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

AdoptedReference Number: EMEA/CHMP/EWP/356954/2008Legal effective date: 01/05/2010

Overview of comments for the guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension

AdoptedReference Number: EMEA/CHMP/EWP/582423/2009

Draft guideline on the use of bovine serum in the manufacture of human biological medicinal products

Draft: consultation closedConsultation dates: 01/10/2012 to 31/12/2012Reference Number: EMA/CHMP/BWP/457920/2012 Rev. 1Summary:

This guideline replaces the note for guidance on the use of bovine serum in the manufacture of human biological medicinal products (CPMP/BWP/1793/02).

Concept paper on the development of a CHMP guideline on the clinical investigation of medicinal products for the treatment of pulmonary hypertension

Reference Number: EMEA/CHMP/EWP/566954/2007