Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 13 March 2018


Chronic thromboembolic pulmonary hypertension (CTEPH)
Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with
- inoperable CTEPH,
- persistent or recurrent CTEPH after surgical treatment,
to improve exercise capacity.

Pulmonary arterial hypertension (PAH)
Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity.
Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease.

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Category Value
Agency product number EMEA/H/C/002737
Orphan designation Yes
Date First Approved 27-03-2014
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Bayer AG

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