EMA Authorised: Opsumit (macitentan) — Janssen-Cilag International N.V.

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Summary

Opsumit (macitentan) has been authorised in the EU for pulmonary arterial hypertension as a new therapeutic option.

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Diseases / indications

• Pulmonary Arterial Hypertension

Drugs mentioned

• OPSUMIT (macitentan)

Snippet

Status: Authorised. Therapeutic area: Hypertension, Pulmonary. MAH: Janssen-Cilag International N.V.. Decision date: 23/04/2026