Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Defitelio   
Auth. number : EU/1/13/878
INN : defibrotide
Orphan status based on designation EU/3/04/211 added on 22/10/2013
Orphan status based on designation EU/3/04/212 added on 22/10/2013
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B01 - Antithrombotic agents
Pharmacological subgroup: B01A - Antithrombotic agents
Chemical subgroup: B01AX - Other antithrombotic agents
Chemical substance: B01AX01 - Defibrotide
(See WHO ATC Index)
Indication: 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.
Marketing Authorisation Holder: Gentium S.p.A.
Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which continues to be available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
22/10/2013 Centralised - Authorisation EMEA/H/C/2393 (2013)7045 of 18/10/2013
20/03/2014 Centralised - Variation EMEA/H/C/2393/II/1