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Ireland· IE-PA-EU/1/97/047/005

BeneFIX 500 IU powder and solvent for solution for injection

A coagulation factor ix product containing nonacog alfa, registered in Ireland by Pfizer Europe MA EEIG. The same ATC class is registered in 12 of our 19 countries.

ATC B02BD04

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedBeneFIX 500 IU powder and solvent for…ATCB02BD04REGISTER NO.IE-PA-EU/1/97/047/005PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Coagulation factor ix is registered in 12 of 19 countries.

Countries holding a registration under ATC B02BD04 (coagulation factor ix), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 8 of them publish a price we can compare per daily dose

Coagulation factor ix · ATC B02BD04

12 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • Switzerlandprice
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

HPRA (Ireland)
Active substance
Nonacog alfa
Manufacturer
Pfizer Europe MA EEIG
Country
Ireland (IE)
ATC code
B02BD04
ATC class
Coagulation factor IX
Defined daily dose
600 E, P
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/97/047/005

Regulatory notes

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

Interactions

3 interactions on record for coagulation factor ix.

Graded by severity as the source publishes them — 2 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

Coagulation factor ix · interactions on record

3 records

  • 2 severe
  • 1 moderate

Most severe, free to view

  • CarfilzomibL01XG02severe
  • CarfilzomibL01XX45severe
  • PegvaliaseA16AB19moderate
  • 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

Coagulation factor ix in 14 other countries

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

All coagulation factor ix products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Benefix, Rixubis
  • Liechtenstein · Benefix, Rixubis
  • Norway · Benefix, Rixubis

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 HPRA (Ireland). 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/bf5e0c33-f44f-45b5-9adc-5ecc94abeb4d
GET /v1/drugs/bf5e0c33-f44f-45b5-9adc-5ecc94abeb4d?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": "Powder and solvent for solution for injection",
  "routes": [
    "Intravenous use"
  ],
  "source": "hpra",
  "atc_all": [
    "B02BD",
    "B02BD04"
  ],
  "strength": null,
  "pa_number": "EU/1/97/047/005",
  "substances": [
    "Nonacog alfa"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": null,
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

See everything about coagulation factor ix.

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.