Opsumit
macitentan
Table of contents
Overview
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.
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List item
Opsumit : EPAR - Medicine overview (PDF/77.53 KB)
First published: 07/02/2014
Last updated: 03/09/2018
EMA/670241/2013 -
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List item
Opsumit : EPAR - Risk-management-plan summary (PDF/102.45 KB)
First published: 24/06/2020
Last updated: 23/03/2022
Authorisation details
Product details | |
---|---|
Name |
Opsumit
|
Agency product number |
EMEA/H/C/002697
|
Active substance |
Macitentan
|
International non-proprietary name (INN) or common name |
macitentan
|
Therapeutic area (MeSH) |
Hypertension, Pulmonary
|
Anatomical therapeutic chemical (ATC) code |
C02KX04
|
Orphan |
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 | |
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Marketing-authorisation holder |
Janssen-Cilag International N.V.
|
Revision |
22
|
Date of issue of marketing authorisation valid throughout the European Union |
20/12/2013
|
Contact address |
Janssen-Cilag International N.V. |
Product information
01/12/2022 Opsumit - EMEA/H/C/002697 - II/0047
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Antihypertensives
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.