Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 04 September 2018

Indication(s)

Opsumit, 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.

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Category Value
Agency product number EMEA/H/C/002697
Orphan designation Yes
Date First Approved 20-12-2013
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Actelion Registration Ltd
Warnings

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reacti