Defitelio is a medicine used to treat severe veno-occlusive disease (VOD) in patients undergoing haematopoietic (blood) stem cell transplantation. VOD is a condition in which the veins in the liver become blocked and stop the liver working properly. Defitelio is used in adults and in children from one month of age.
Defitelio contains the active substance defibrotide.
VOD is rare, and Defitelio was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 29 July 2004.
Defitelio : EPAR - Medicine overview (PDF/116.94 KB) (updated)
First published: 25/10/2013
Last updated: 19/11/2019
Defitelio : EPAR - Risk-management-plan summary (PDF/87.25 KB)
First published: 19/11/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Hepatic Veno-Occlusive Disease
|Anatomical therapeutic chemical (ATC) code||
This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.
|Date of issue of marketing authorisation valid throughout the European Union||
19/09/2019 Defitelio - EMEA/H/C/002393 - II/0043
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.