EMA
approval
· 2023-12-20
EMA Authorised: Defitelio (defibrotide) — Gentium S.r.l.
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
Snippet
Status: Authorised. Therapeutic area: Hepatic Veno-Occlusive Disease. MAH: Gentium S.r.l.. Decision date: 19/12/2023