France· FR:69439245
DEFITELIO 80 mg/mL solution à diluer pour perfusion
A defibrotide product containing défibrotide, registered in France by GENTIUM (ITALIE). The same ATC class is registered in 15 of our 19 countries.
Checked against Base de données publique des médicaments — BDPM (France) 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: France, from Base de données publique des médicaments — BDPM (France)
- 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
Base de données publique des médicaments — BDPM (France)- Active substance
- DÉFIBROTIDE
- Manufacturer
- GENTIUM (ITALIE)
- Country
- France (FR)
- ATC code
- B01AX01
- ATC class
- Defibrotide
- Defined daily dose
- 1.75 g, P
- Reimbursed
- No
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 1
- cip13340095857946210 flacon(s) en verre de 2,5 ml
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.
- NetherlandsDefitelio 80 mg/ml concentraat voor oplossing voor infusieGentium S.p.A.
- United KingdomDefitelio 200mg/2.5ml concentrate for solution for infusion vialsJazz Pharmaceuticals UK Ltd
- CanadaDEFITELIOJAZZ PHARMACEUTICALS IRELAND LIMITED
- 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.
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 Base de données publique des médicaments — BDPM (France). 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/324320d7-a0a4-4629-9533-be84242a0f8f GET /v1/drugs/324320d7-a0a4-4629-9533-be84242a0f8f?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.
{
"cis": "69439245",
"date_amm": "2013-10-18",
"type_amm": "Procédure centralisée",
"numero_ue": "EU/1/13/878",
"substance": "DÉFIBROTIDE",
"atc_source": "fr_atc_restore_2026-09-06",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "solution à diluer pour perfusion",
"voies_administration": "intraveineuse",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Oui"
}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.