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Ireland· IE-PA-EU/1/99/103/006

ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe

A coagulation factor viii product containing moroctocog alfa, registered in Ireland by Pfizer Europe MA EEIG. The same ATC class is registered in 11 of our 19 countries.

ATC B02BD02

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedReFacto AF 500 IU powder and solvent …ATCB02BD02REGISTER NO.IE-PA-EU/1/99/103/006PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about moroctocog alfaAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Coagulation factor viii is registered in 11 of 19 countries.

Countries holding a registration under ATC B02BD02 (coagulation factor viii), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 7 of them publish a price we can compare per daily dose
Search coagulation factor viii products by name

Coagulation factor viii · ATC B02BD02

11 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • 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
Moroctocog alfa
Manufacturer
Pfizer Europe MA EEIG
Country
Ireland (IE)
ATC code
B02BD02
ATC class
Coagulation factor VIII
Defined daily dose
1 TSD, E
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/99/103/006

Regulatory notes

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

Interactions

4 interactions on record for coagulation factor viii.

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
Check coagulation factor viii against other medicinesHow interaction checks work

Coagulation factor viii · interactions on record

4 records

  • 2 severe
  • 2 moderate

Most severe, free to view

  • CarfilzomibL01XG02severe
  • CarfilzomibL01XX45severe
  • PegvaliaseA16AB19moderate
  • EmicizumabB02BX06moderate
  • 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 viii in 12 other countries

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

All coagulation factor viii products

Authorised across Europe · EMA

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

  • Iceland · Refacto Af
  • Liechtenstein · Refacto Af
  • Norway · Refacto Af

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/ea0c67a6-0569-4018-928b-683823cd5a7b
GET /v1/drugs/ea0c67a6-0569-4018-928b-683823cd5a7b?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 in pre-filled syringe",
  "routes": [
    "Intravenous use"
  ],
  "source": "hpra",
  "atc_all": [
    "B02BD",
    "B02BD02"
  ],
  "strength": null,
  "pa_number": "EU/1/99/103/006",
  "substances": [
    "Moroctocog alfa"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "06/05/2011",
  "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
}
API referenceMCP serverPlans

See everything about coagulation factor viii.

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