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EMA approval · 2023-12-20

EMA Authorised: Defitelio (defibrotide) — Gentium S.r.l.

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Summary

Defitelio (defibrotide) has been authorised by the EMA for hepatic veno-occlusive disease, with Gentium S.r.l. as the marketing authorization holder.

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Diseases / indications

Drugs mentioned

  • Defitelio (defibrotide)

Snippet

Status: Authorised. Therapeutic area: Hepatic Veno-Occlusive Disease. MAH: Gentium S.r.l.. Decision date: 19/12/2023