Ireland· IE-PA-EU/01/13/878/001
Defitelio 80 mg/mL concentrate for solution for infusion
A defibrotide product containing defibrotide, registered in Ireland by Gentium S.p.A.. The same ATC class is registered in 15 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Defibrotide is registered in 15 of 19 countries.
Countries holding a registration under ATC B01AX01 (defibrotide), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 9 of them publish a price we can compare per daily dose
Defibrotide · ATC B01AX01
15 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Defibrotide
- Manufacturer
- Gentium S.p.A.
- Country
- Ireland (IE)
- ATC code
- B01AX01
- ATC class
- Defibrotide
- Defined daily dose
- 1.75 g, P
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/01/13/878/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
136 interactions on record for defibrotide.
Graded by severity as the source publishes them — 71 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Defibrotide · interactions on record
136 records
- 71 severe
- 65 moderate
Most severe, free to view
- DicoumarolB01AA01severe
- WarfarinB01AA03severe
- HeparinB01AB01severe
- Antithrombin IIIB01AB02severe
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Defibrotide in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumDefitelio 80 mg/mlGentium
- SwitzerlandDefitelio 80 mg/ml, Konzentrat zur Herstellung einer InfusionslösungJazz Pharmaceuticals Switzerland GmbH
- CzechiaDEFITELIOGentium S.r.l., Villla Guardia, Como
- FinlandDefitelioGentium S.r.l.
- IcelandDefitelioGentium S.r.l.
- NorwayDefitelioGentium S.r.l.
- PolandDefitelioGentium S.r.l.
- SwedenDefitelio 80 mg/ml Koncentrat till infusionsvätska, lösningGentium S.r.l.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Defitelio
- Liechtenstein · Defitelio
- Norway · Defitelio
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of HPRA (Ireland). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/c1bbb9c2-e755-4779-9874-20bb2a8851b5 GET /v1/drugs/c1bbb9c2-e755-4779-9874-20bb2a8851b5?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"form": "Concentrate for solution for infusion",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"B01AX",
"B01AX01"
],
"strength": null,
"pa_number": "EU/01/13/878/001",
"substances": [
"Defibrotide"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "18/10/2013",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about defibrotide.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.