Basic Information
Opsumit
Regulatory Information
EMEA/H/C/002697
December 20, 2013
25
November 26, 2024
Company Information
Belgium
Turnhoutseweg 30 BE-2340 Beerse
Janssen-Cilag International NV
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Adults 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. Paediatric population Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged less than 18 years and bodyweight ≥ 40 kg with WHO Functional Class (FC) II to III. Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged 2 years to less than 18 years with WHO Functional Class (FC) II to III.
Overview Summary
Opsumit is a medicine used for the long-term treatment of pulmonary arterial hypertension (PAH), 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, adolescents and children aged 2 years and older in whom PAH comes with moderate or marked limitations in physical activity (corresponding to WHO functional class II or III, respectively). Opsumit can be used alone or in combination with other PAH medicines. Opsumit contains the active substance macitentan.