Belgium· BE-AMP-SAM448346-00
Defitelio 80 mg/ml
A defibrotide product containing defibrotide, registered in Belgium by Gentium. The same ATC class is registered in 15 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) 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: Belgium, from FAMHP / AFMPS (Belgium)
- 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
FAMHP / AFMPS (Belgium)- Active substance
- Defibrotide
- Manufacturer
- Gentium
- Country
- Belgium (BE)
- ATC code
- B01AX01
- ATC class
- Defibrotide
- Defined daily dose
- 1.75 g, P
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 1
- be_apb3461662
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.
- SwitzerlandDefitelio 80 mg/ml, Konzentrat zur Herstellung einer InfusionslösungJazz Pharmaceuticals Switzerland GmbH
- CzechiaDEFITELIOGentium S.r.l., Villla Guardia, Como
- FinlandDefitelioGentium S.r.l.
- IrelandDefitelio 80 mg/mL concentrate for solution for infusionGentium S.p.A.
- 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 FAMHP / AFMPS (Belgium). 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/f6b6b321-0008-4f61-8c56-6bab5c07c302 GET /v1/drugs/f6b6b321-0008-4f61-8c56-6bab5c07c302?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",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Defitelio 80 mg/ml",
"name_fr": "Defitelio 80 mg/ml",
"name_nl": "Defitelio 80 mg/ml",
"amp_code": "SAM448346-00",
"strengths": [
"80.0000"
],
"pack_count": 1,
"substances": [
"Defibrotide",
"Sodium Hydroxide"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Defibrotide",
"authorisation_numbers": [
"EU/1/13/878/001"
]
}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.