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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/13/878|
|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
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.
|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|