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EMA approval · 2026-04-23

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

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Summary

EMA authorised Opsumit (macitentan) by Janssen-Cilag International N.V. for pulmonary arterial hypertension. This marks EU authorization of the medicine for thi…

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Diseases / indications

Drugs mentioned

  • OPSUMIT (macitentan)

Snippet

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