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Netherlands· NL-0e14d9d27093

Defitelio 80 mg/ml concentraat voor oplossing voor infusie

A defibrotide product containing defibrotide, registered in Netherlands by Gentium S.p.A.. The same ATC class is registered in 15 of our 19 countries.

ATC B01AX01

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedDefitelio 80 mg/ml concentraat voor o…ATCB01AX01REGISTER NO.NL-0e14d9d27093PACKS LISTED1CHECKEDSeptember 29, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about defibrotideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Netherlands, from CBG-MEB (Netherlands)
  • 9 of them publish a price we can compare per daily dose
Search defibrotide products by name

Defibrotide · ATC B01AX01

15 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

CBG-MEB (Netherlands)
Active substance
DEFIBROTIDE
Manufacturer
Gentium S.p.A.
Country
Netherlands (NL)
ATC code
B01AX01
ATC class
Defibrotide
Defined daily dose
1.75 g, P
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/13/878

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
Check defibrotide against other medicinesHow interaction checks work

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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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.

All defibrotide products

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 CBG-MEB (Netherlands). 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/166880e9-8985-421b-b939-ca4d722e0ee8
GET /v1/drugs/166880e9-8985-421b-b939-ca4d722e0ee8?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": "Concentraat voor oplossing voor infusie",
  "route": "Intraveneus gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/defitelio-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Defibrotide",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp110056",
  "excipients": [
    "NATRIUMHYDROXIDE (E 524)",
    "STIKSTOF (HEAD SPACE) (E 941)",
    "TRINATRIUMCITRAAT 2-WATER (E 331)",
    "WATER VOOR INJECTIE",
    "ZOUTZUUR (E 507)"
  ],
  "substances": [
    "DEFIBROTIDE"
  ],
  "leaflet_url": null,
  "authorised_at": "2013/10/18",
  "procedure_number": "EMEA/H/C/002393",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/13/878",
  "additional_monitoring": "Y"
}
API referenceMCP serverPlans

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.

Try it freeOpen in the console