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SCIENTIFIC DISCUSSION 1. Introduction

1/24 EMEA 2005 SCIENTIFIC DISCUSSION 1. Introduction Revatio 20 mg film-coated tablet is indicated for the Treatment of patients with pulmonary arterial hypertension classified as WHO functional class III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. The active substance is sildenafil. The recommended dose is 20 mg three times a day. PAH is a disease of the small pulmonary arteries that is characterised by vascular proliferation and remodelling. It results in a progressive increase in pulmonary arterial resistance and, ultimately, right ventricular failure and death. PAH is defined by right-heart catheterization showing a precapillary pulmonary hypertension (mean pulmonary artery pressure > 25 mmHg at rest or > 30 mmHg with exercise, with a pulmonary artery wedge pressure < 15 mmHg).

1/24 ©EMEA 2005 SCIENTIFIC DISCUSSION 1. Introduction Revatio 20 mg film-coated tablet is indicated for the Treatment of patients with pulmonary arterial

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