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EMA approval · 2026-08-07

EMA Authorised: Epysqli (Eculizumab) — Samsung Bioepis NL B.V.

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Summary

Epilishi (Eculizumab) from Samsung Bioepis NL B.V. has been authorised by EMA for its indicated use in paroxysmal nocturnal hemoglobinuria.

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Diseases / indications

Drugs mentioned

  • EPYSQLI (eculizumab-aagh)

Snippet

Status: Authorised. Therapeutic area: Hemoglobinuria, Paroxysmal. MAH: Samsung Bioepis NL B.V.. Decision date: 07/08/2026