Back to search

Poland· PL-100332510

Biwalirudyna Accord

A bivalirudin product containing bivalirudinum, registered in Poland by Accord Healthcare Polska Sp. z o.o.. The same ATC class is registered in 11 of our 19 countries.

ATC B01AE06

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedBiwalirudyna AccordATCB01AE06REGISTER NO.PL-100332510PACKS LISTED4CHECKEDSeptember 27, 2026

Where it is registered

Bivalirudin is registered in 11 of 19 countries.

Countries holding a registration under ATC B01AE06 (bivalirudin), each read from that country’s own register.

  • This record: Poland, from URPL (Poland)
  • 5 of them publish a price we can compare per daily dose

Bivalirudin · ATC B01AE06

11 / 19 countries

  • Belgiumprice
  • Canada
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Netherlands
  • Polandprice
  • Sweden
  • 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
Bivalirudinum
Manufacturer
Accord Healthcare Polska Sp. z o.o.
Country
Poland (PL)
ATC code
B01AE06
ATC class
Bivalirudin
Defined daily dose
0.25 g, P
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 4

  • gtin
    05909991296520
  • gtin
    05909991296537
  • gtin
    04150139692051
  • gtin
    05909991296544

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

148 interactions on record for bivalirudin.

Graded by severity as the source publishes them — 63 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

Bivalirudin · interactions on record

148 records

  • 63 severe
  • 85 moderate

Most severe, free to view

  • DicoumarolB01AA01severe
  • WarfarinB01AA03severe
  • HeparinB01AB01severe
  • DalteparinB01AB04severe
  • 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

Bivalirudin in 10 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All bivalirudin products

Authorised across Europe · EMA

The same active substance is authorised in 13 EEA countries. Names it is sold under:

  • Austria · Bivalirudin Accord
  • Belgium · Bivalirudin Accord Healthcare, Bivalirudin Hikma
  • Germany · Bivalirudin Accord
  • Denmark · Bivalirudin Reig Jofre
  • Spain · Bivalirudina Hikma, Bivalirudina Sala
  • Finland · Bivalirudin Bioglan
  • France · Bivalirudine Accord, Bivalirudine Hikma
  • United Kingdom (Northern Ireland) · Bivalirudin Accord Healthcare, Bivalirudin Kensington Pharma
  • Italy · Bivalirudina Accord, Bivalirudina Hikma
  • Netherlands · Bivalirudine Accord, Bivalirudine Hikma
  • Portugal · Bivalirudina Accord, Bivalirudina Hikma
  • Sweden · Bivalirudin Reig Jofre
  • Slovenia · Bivalirudin Accord

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/4351207d-5d45-432c-87b9-7f520bc9291a
GET /v1/drugs/4351207d-5d45-432c-87b9-7f520bc9291a?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": "Proszek do sporządzania koncentratu roztworu do wstrzykiwań lub infuzji",
  "source": "urpl",
  "strength": "250 mg",
  "packaging": "05909991296520 ¦ Rpz ¦ 118049\n1 fiol. 250 mg\n05909991296537 ¦ Rpz ¦ 118050\n5 fiol. 250 mg\n¦ UR/Z/4c/014/21 - 04150139692051 ¦ UR/Z/4c/039/22 - 04150139692051\n05909991296544 ¦ Rpz ¦ 118051\n10 fiol. 250 mg",
  "substance": "Bivalirudinum 250 mg",
  "common_name": "Bivalirudinum",
  "pl_product_id": "100332510",
  "pozwolenie_nr": "23487",
  "auth_procedure": "DCP",
  "authorisation_validity": "Bezterminowe"
}

See everything about bivalirudin.

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.