Defitelio

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defibrotide

Authorised
This medicine is authorised for use in the European Union.

Overview

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. 

This EPAR was last updated on 19/11/2019

Authorisation details

Product details
Name
Defitelio
Agency product number
EMEA/H/C/002393
Active substance
defibrotide
International non-proprietary name (INN) or common name
defibrotide
Therapeutic area (MeSH)
Hepatic Veno-Occlusive Disease
Anatomical therapeutic chemical (ATC) code
B01AX01
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Exceptional circumstancesExceptional circumstances

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.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Gentium S.r.l.
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
18/10/2013
Contact address
Piazza XX Settembre 2
22079 Villa Guardia (Como)
Italy

Product information

19/09/2019 Defitelio - EMEA/H/C/002393 - II/0043

Contents

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Pharmacotherapeutic group

Antithrombotic agents

Therapeutic 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.

Assessment history

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