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Irish Medicines Database · HPRA register

Defitelio 80 mg/mL concentrate for solution for infusion

Authorisation EU/01/13/878/001 · Gentium S.p.A.

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Defitelio 80 mg/mL concentrate for solution for infusion
Licence EU/01/13/878/001 · Unknown
Licence holder
Gentium S.p.A. (all products →)
Active substance
Defibrotide
Dosage form
Concentrate for solution for infusion
Route of administration
Intravenous use
ATC codes
B01AX, B01AX01
First authorised
18/10/2013
Prescription status
Product subject to prescription which may not be renewed (A)
Supply
Supply through pharmacies only
Legal basis
Full application (Article 8(3) of Directive No 2001/83/EC)

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 04 Jul 2026. This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.