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.
Opsumit : EPAR - Medicine overview (PDF/77.53 KB)
First published: 07/02/2014
Last updated: 03/09/2018
Opsumit : EPAR - Risk-management-plan summary (PDF/71.49 KB)
First published: 24/06/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Janssen-Cilag International N.V.
|Date of issue of marketing authorisation valid throughout the European Union||
17/04/2020 Opsumit - EMEA/H/C/002697 - II/0035/G
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.