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Union Register of medicinal products for human use


Product information

Invented name: Defitelio   
Auth. number : EU/1/13/878
Active substance : defibrotide
Orphan market exclusivity for "Treatment of hepatic veno-occlusive disease" (based on designation EU/3/04/212) started on 22/10/2013
   10 years of market exclusivity
   This orphan market exclusivity will expire on 22/10/2023
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.r.I.
Piazza XX Settembre, 2, 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 is available in the Union 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
Updated with Decision(2015)114 of 12/01/2015
14/01/2015 Centralised - Yearly update (2015)114 of 12/01/2015
22/01/2015 Centralised - Variation EMEA/H/C/2393/II/2/G
Updated with Decision(2016)638 of 28/01/2016
11/03/2015 Centralised - Variation EMEA/H/C/2393/IA/7/G
Updated with Decision(2016)638 of 28/01/2016
24/04/2015 Centralised - Annual reassessment EMEA/H/C/2393/S/5
5/02/2016 Centralised - Variation EMEA/H/C/2393/IAIN/15/G
Updated with Decision(2017)176 of 11/01/2017
5/02/2016 Centralised - Yearly update (2016)638 of 28/01/2016
18/03/2016 Centralised - Variation EMEA/H/C/2393/IB/16
Updated with Decision(2017)176 of 11/01/2017
28/04/2016 Centralised - Annual reassessment EMEA/H/C/2393/S/13
26/05/2016 Centralised - Variation EMEA/H/C/2393/II/12
Updated with Decision(2017)176 of 11/01/2017
16/01/2017 Centralised - Yearly update (2017)176 of 11/01/2017
21/04/2017 Centralised - Notification EMEA/H/C/2393/N/23
Updated with Decision(2018)5092 of 26/07/2018
12/04/2018 Centralised - Variation EMEA/H/C/2393/II/26
Updated with Decision(2018)5092 of 26/07/2018
28/06/2018 Centralised - Variation EMEA/H/C/2393/II/27
30/07/2018 Centralised - Renewal EMEA/H/C/2393/R/32 (2018)5092 of 26/07/2018
20/12/2018 Centralised - Notification EMEA/H/C/002393/N/0037
26/03/2019 Centralised - Notification EMEA/H/C/002393/N/0041