Defitelio

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defibrotide

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

Overview

This is a summary of the European public assessment report (EPAR) for Defitelio. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Defitelio.

For practical information about using Defitelio, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 16/05/2017

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 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 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.

Orphan

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
6
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

21/04/2017 Defitelio - EMEA/H/C/002393 - N/0023

Contents

  • 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.

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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