Defitelio
What Defitelio is used for
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.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Approved under exceptional circumstances: full data cannot be collected, usually because the disease is very rare.
Key facts
- Brand
- Defitelio
- Active substance
- defibrotide
- Disease area
- Hepatic Veno-Occlusive Disease
- Medicine group
- Antithrombotic agents
- ATC code
- B01AX01
- Marketing authorisation holder
- Gentium S.r.l.
- Authorised in the EU since
- 2013
Official information
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Defitelio used for?
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.
What is the active substance in Defitelio?
Defitelio contains defibrotide.
Who makes Defitelio?
The EU marketing authorisation holder is Gentium S.r.l..
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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