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An official government website affiliated with the Government of the Kingdom of Saudi Arabia.
icon Thu 13 Aug 2026
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20250831619
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Drug Approvals

SFDA Approved Use
Macitentan, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.
Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease