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.
Checked against URPL (Poland) on
Informational only — not a medical device.
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
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
- gtin05909991296520
- gtin05909991296537
- gtin04150139692051
- gtin05909991296544
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.
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.
- FinlandAngioxOrifarm Oy
- United KingdomAngiox 250mg powder for concentrate for solution for infusion vialsThe Medicines Company UK Ltd
- BelgiumAngiox 250 mgThe Medicines Company
- SpainBIVALIRUDINA ACCORD 250 MG DE POLVO PARA CONCENTRADO PARA SOLUCION INYECTABLE Y PARA PERFUSION EFGAccord Healthcare S.L.U.
- SwedenBivalirudin Reig Jofre 250 mg Pulver till koncentrat till injektions-/infusionsvätska, lösningBioglan AB
- United StatesbivalirudinSlate Run Pharmaceuticals, LLC
- CanadaANGIOMAXSANDOZ CANADA INCORPORATED
- NetherlandsBivalirudine Accord 250 mg poeder voor concentraat voor oplossing voor injectie/infusieAccord Healthcare B.V.
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.