This medicine is authorised for use in the European Union.


Opsumit is a medicine used for the long-term treatment of pulmonary arterial hypertension (PAH). PAH is a condition in which there is abnormally high blood pressure in the arteries of the lungs, causing symptoms such as breathlessness and fatigue.

Opsumit is used for adults whose PAH is classified as WHO functional class II to class III. The class reflects the seriousness of the disease: patients with class II PAH have slight limitation of physical activity and those with class III disease have marked limitation of physical activity. Opsumit can be used alone or in combination with other PAH medicines; for further information, see the package leaflet.

PAH is ‘rare’, and Opsumit was designated an ‘orphan medicine’ (a medicine used in rare diseases) for PAH on 27 September 2011.

Opsumit contains the active substance macitentan.

This EPAR was last updated on 24/03/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Janssen-Cilag International N.V.  
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Janssen-Cilag International N.V.
Turnhoutseweg 30
BE-2340 Beerse

Product information

01/12/2022 Opsumit - EMEA/H/C/002697 - II/0047

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


Therapeutic indication

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.

Assessment history

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