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Ireland· IE-PA-PA22583/002/001

Sublimaze 50 micrograms/ml solution for injection

A fentanyl product containing fentanyl citrate, registered in Ireland by Piramal Critical Care B.V.. The same ATC class is registered in 12 of our 19 countries.

ATC N01AH01

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedSublimaze 50 micrograms/ml solution f…ATCN01AH01REGISTER NO.IE-PA-PA22583/002/001PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Fentanyl is registered in 12 of 19 countries.

Countries holding a registration under ATC N01AH01 (fentanyl), 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

Fentanyl · ATC N01AH01

12 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Japan
  • 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
FENTANYL CITRATE
Manufacturer
Piramal Critical Care B.V.
Country
Ireland (IE)
ATC code
N01AH01
ATC class
Fentanyl
Defined daily dose
0.7 mg, P
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PA22583/002/001

Regulatory notes

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

Interactions

444 interactions on record for fentanyl.

Graded by severity as the source publishes them — 70 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

Fentanyl · interactions on record

444 records

  • 70 severe
  • 154 moderate
  • 220 info

Most severe, free to view

  • ClotrimazoleA01AB18severe
  • OndansetronA04AA01severe
  • GranisetronA04AA02severe
  • DolasetronA04AA04severe
  • 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

Fentanyl in 17 other countries

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

All fentanyl products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Actiq, Durogesic
  • Belgium · Durogesic, Fentanyl Matrix Eg
  • Bulgaria · Fentadolor, Sublifen
  • Cyprus · Abstral, Lavifent
  • Czechia · Adolor, Dolforin
  • Germany · Abstral, Actiq
  • Denmark · Abstral, Actiq
  • Estonia · Fentanyl Basi, Fentanyl Kalceks
  • Spain · Abattra, Abfentiq
  • Finland · Durogesic, Fentanyl Basi
  • France · Abstral, Actiq
  • United Kingdom (Northern Ireland) · Abstral, Actiq
  • Greece · Abstral, Actiq
  • Croatia · Durogesic, Fentanil Kalceks
  • Hungary · Dolforin, Durogesic
  • Iceland · Durogesic, Fentanyl Actavis
  • Italy · Abstral, Actiq
  • Liechtenstein · Pecfent
  • Lithuania · Dolforin, Fentanyl Kalceks
  • Luxembourg · Durogesic, Fentanyl Hameln
  • Latvia · Dolforin, Fentanyl Citrate Kalceks
  • Malta · Fentadur, Fentanyl Kalceks
  • Netherlands · Abstral, Actiq
  • Norway · Abstral, Durogesic
  • Poland · Aurofena, Durogesic
  • Portugal · Abstral, Actiq
  • Romania · Fentanil Kalceks, Fentanyl Lavipharm
  • Sweden · Abstral, Actiq
  • Slovenia · Durogesic, Epufen
  • Slovakia · Breakyl, Fentanyl Kalceks

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/5af3bf6c-3e45-4985-8c28-0e12ee0bdcde
GET /v1/drugs/5af3bf6c-3e45-4985-8c28-0e12ee0bdcde?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": "Solution for injection",
  "routes": [
    "Intravenous use"
  ],
  "source": "hpra",
  "atc_all": [
    "N01AH",
    "N01AH01"
  ],
  "strength": null,
  "pa_number": "PA22583/002/001",
  "substances": [
    "FENTANYL CITRATE"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Not marketed",
  "authorised_at": "10/06/1997",
  "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 fentanyl.

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.