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Opsumit (macitentan)

Region
🇪🇺 EU
Active substance
macitentan
Status
Authorised
Therapeutic area
Hypertension, Pulmonary
EU approval
Fri 20 Dec 2013
Application
EMEA/H/C/002697
ATC
C02KX04
Official record
www.ema.europa.eu

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 populationOpsumit, 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.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.