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🇪🇺EU · EMAAuthorisedATC: B01AX01

Defitelio(defibrotide)

Hepatic Veno-Occlusive Disease

Marketing Authorisation Holder: Gentium S.r.l.

EMA Authorisation: 18/10/2013

INN: defibrotide

Indication

Defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstructive syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy. It is indicated in adults and in adolescents, children and infants over 1 month of age.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.