EMA
approval
· 2026-04-23
EMA Authorised: Opsumit (macitentan) — Janssen-Cilag International N.V.
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
Snippet
Status: Authorised. Therapeutic area: Hypertension, Pulmonary. MAH: Janssen-Cilag International N.V.. Decision date: 23/04/2026