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Ireland· IE-PA-EU/1/23/1726/001

Opzelura 15 mg/g Cream

A ruxolitinib product containing ruxolitinib, registered in Ireland by Incyte Biosciences Distribution B.V.. The same ATC class is registered in 14 of our 19 countries.

ATC D11AH09

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedOpzelura 15 mg/g CreamATCD11AH09REGISTER NO.IE-PA-EU/1/23/1726/001PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about ruxolitinibAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Ruxolitinib is registered in 14 of 19 countries.

Countries holding a registration under ATC D11AH09 (ruxolitinib), each read from that country’s own register.

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

Ruxolitinib · ATC D11AH09

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • 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
Ruxolitinib
Manufacturer
Incyte Biosciences Distribution B.V.
Country
Ireland (IE)
ATC code
D11AH09
ATC class
Ruxolitinib
Defined daily dose
30 mg, T
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/23/1726/001

Regulatory notes

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

Same medicine, other countries

Ruxolitinib in 15 other countries

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

All ruxolitinib products

Authorised across Europe · EMA

The same active substance is authorised in 23 EEA countries. Names it is sold under:

  • Austria · Polink, Ruxib
  • Bulgaria · Руджави, Руксолитиниб Сандоз
  • Cyprus · Ruxolitinib Sandoz
  • Czechia · Ruxolitinib Msn, Ruxolitinib Sandoz
  • Denmark · Ruxolitinib "sandoz", Ruxolitinib Devatis
  • Estonia · Ruxolitinib Msn
  • Spain · Ruxolitinib Cipla, Ruxolitinib Vivanta
  • Finland · Ruxolitinib Orion
  • France · Ruxolitinib Biogaran, Ruxolitinib Olpha
  • United Kingdom (Northern Ireland) · Ruxolitinib Msn Laboratories Europe, Ruxolitinib Torrent
  • Greece · Jakulya
  • Croatia · Ruksolitinib Devatis, Ruksolitinib Msn
  • Hungary · Ruxolitinib Sandoz
  • Iceland · Jakavi, Jakulya
  • Italy · Ruxolitinib Vivanta
  • Liechtenstein · Jakavi, Opzelura
  • Lithuania · Ruxolitinib Msn, Ruxolitinib Olpha
  • Latvia · Ruxolitinib Msn
  • Malta · Donlize, Ruxolitinib Medichem
  • Netherlands · Ruxolitinib Accord, Ruxolitinib Advanz Pharma
  • Norway · Jakavi, Opzelura
  • Romania · Ruxolitinib Msn
  • Sweden · Ruxolitinib Devatis, Ruxolitinib Orion

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/c4f85df1-f0ab-4739-9804-5a07f53a62b4
GET /v1/drugs/c4f85df1-f0ab-4739-9804-5a07f53a62b4?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": "Cream",
  "routes": [
    "Cutaneous use"
  ],
  "source": "hpra",
  "atc_all": [
    "D11AH",
    "D11AH09"
  ],
  "strength": null,
  "pa_number": "EU/1/23/1726/001",
  "substances": [
    "Ruxolitinib"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "19/04/2023",
  "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 ruxolitinib.

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.

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