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Ireland· IE-PA-PA20595/001/001

Fomepizole SERB 5 mg/mL, concentrate for solution for infusion.

A fomepizole product containing fomepizole sulphate, registered in Ireland by SERB S.A.. The same ATC class is registered in 14 of our 19 countries.

ATC V03AB34

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedFomepizole SERB 5 mg/mL, concentrate …ATCV03AB34REGISTER NO.IE-PA-PA20595/001/001PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Fomepizole is registered in 14 of 19 countries.

Countries holding a registration under ATC V03AB34 (fomepizole), 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

Fomepizole · ATC V03AB34

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • 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

HPRA (Ireland)
Active substance
Fomepizole sulphate
Manufacturer
SERB S.A.
Country
Ireland (IE)
ATC code
V03AB34
ATC class
Fomepizole
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PA20595/001/001

Regulatory notes

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

Interactions

4 interactions on record for fomepizole.

Graded by severity as the source publishes them — 4 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

Fomepizole · interactions on record

4 records

  • 4 severe

Most severe, free to view

  • EthanolB05XX04severe
  • EthanolV03AB16severe
  • EthanolV03AZ01severe
  • EthanolV07AB03severe
  • 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

Fomepizole in 6 other countries

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

All fomepizole products

Authorised across Europe · EMA

The same active substance is authorised in 11 EEA countries. Names it is sold under:

  • Austria · Fomepizole Serb
  • Belgium · Fomepizole Serb
  • Germany · Fomepizole Serb
  • Finland · Fomepizole Serb
  • France · Fomepizole Serb
  • Iceland · Fomepizole Serb
  • Luxembourg · Fomepizole Serb
  • Malta · Fomepizole Serb
  • Netherlands · Fomepizole Serb
  • Norway · Fomepizole Serb
  • Sweden · Fomepizole Serb

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/d59d1c48-a82b-4309-a0d2-8003e6789b03
GET /v1/drugs/d59d1c48-a82b-4309-a0d2-8003e6789b03?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": "Concentrate for solution for infusion",
  "routes": [
    "Intravenous use"
  ],
  "source": "hpra",
  "atc_all": [
    "V03AB",
    "V03AB34"
  ],
  "strength": null,
  "pa_number": "PA20595/001/001",
  "substances": [
    "Fomepizole sulphate"
  ],
  "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)",
  "market_info": "Marketed",
  "authorised_at": "11/10/2002",
  "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 fomepizole.

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.