EMA Authorised: Ultomiris (ravulizumab) — Alexion Europe SAS

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Summary

The European Medicines Agency authorised Ultomiris (ravulizumab) for its indicated use under the owner Alexion Europe SAS, with decision dated 11/09/2025.

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Diseases / indications

• Paroxysmal Nocturnal Hemoglobinuria

Drugs mentioned

• ULTOMIRIS (ravulizumab)

Snippet

Status: Authorised. Therapeutic area: Hemoglobinuria, Paroxysmal. MAH: Alexion Europe SAS. Decision date: 11/09/2025