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Poland· PL-100309415

Defitelio

A defibrotide product containing defibrotidum, registered in Poland by Gentium S.r.l.. The same ATC class is registered in 15 of our 19 countries.

ATC B01AX01

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedDefitelioATCB01AX01REGISTER NO.PL-100309415PACKS LISTED3CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about defibrotidumAnswers 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: Poland, from URPL (Poland)
  • 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

URPL (Poland)
Active substance
Defibrotidum
Manufacturer
Gentium S.r.l.
Country
Poland (PL)
ATC code
B01AX01
ATC class
Defibrotide
Defined daily dose
1.75 g, P
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 3

  • gtin
    05909991185923
  • gtin
    00368727105935
  • gtin
    00368727004603

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 URPL (Poland). 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/246e0caf-ead9-4e04-845e-955b4e1e91b1
GET /v1/drugs/246e0caf-ead9-4e04-845e-955b4e1e91b1?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": "Koncentrat do sporządzania roztworu do infuzji",
  "source": "urpl",
  "strength": "80 mg/ml",
  "packaging": "05909991185923 ¦ Rpz ¦ Skasowane ¦ EU/1/13/878/001 ¦ 88720\n10 fiol. 2,5 ml\n00368727105935 ¦ Rpz ¦ EU/1/13/878/001 ¦ 134671\n10 fiol. 2,5 ml\n¦ UR/Z/4c/126/24 - 00368727004603 ¦ UR/Z/4c/183/24 - 00368727004603 ¦ UR/Z/4c/069/25 - 00368727004603 ¦ UR/Z/4c/035/26 - 00368727004603",
  "substance": "Defibrotidum 80 mg/ml",
  "common_name": "Defibrotidum",
  "pl_product_id": "100309415",
  "pozwolenie_nr": null,
  "auth_procedure": "CEN",
  "authorisation_validity": null
}
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