EMA Authorised: Soliris (Eculizumab) — Alexion Europe SAS

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Summary

The EMA authorised Soliris (eculizumab) in the European Union for paroxysmal nocturnal hemoglobinuria. The decision carries orphan medicine designation with acc…

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Diseases / indications

• Paroxysmal Nocturnal Hemoglobinuria

Drugs mentioned

• SOLIRIS (eculizumab)

Snippet

Status: Authorised. Therapeutic area: Hemoglobinuria, Paroxysmal. MAH: Alexion Europe SAS. Decision date: 17/07/2025. Orphan medicine. Accelerated assessment