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EMA approval · 2025-12-19

EMA Authorised: Macitentan Accord (macitentan) — Accord Healthcare

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Summary

The EMA authorised Macitentan Accord for treatment of pulmonary arterial hypertension; the marketing authorisation holder is Accord Healthcare.

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Diseases / indications

Drugs mentioned

  • Macitentan Accord (macitentan)

Snippet

Status: Authorised. Therapeutic area: Hypertension, Pulmonary. MAH: Accord Healthcare. Decision date: 24/09/2025