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Ireland· IE-PA-EU/1/15/1043/003-004

Nucala 100 mg solution for injection in pre-filled pen

A mepolizumab product containing mepolizumab, registered in Ireland by GlaxoSmithKline Trading Services Limited. The same ATC class is registered in 13 of our 19 countries.

ATC R03DX09

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedNucala 100 mg solution for injection …ATCR03DX09REGISTER NO.IE-PA-EU/1/15/1043/00…PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Mepolizumab is registered in 13 of 19 countries.

Countries holding a registration under ATC R03DX09 (mepolizumab), 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

Mepolizumab · ATC R03DX09

13 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Italyprice
  • 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
Mepolizumab
Manufacturer
GlaxoSmithKline Trading Services Limited
Country
Ireland (IE)
ATC code
R03DX09
ATC class
Mepolizumab
Defined daily dose
3.6 mg, P
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/15/1043/003-004

Regulatory notes

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

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/ad4e92de-d9a0-4380-892b-eb1866db20df
GET /v1/drugs/ad4e92de-d9a0-4380-892b-eb1866db20df?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 in pre-filled pen",
  "routes": [
    "Subcutaneous use"
  ],
  "source": "hpra",
  "atc_all": [
    "R03DX09"
  ],
  "strength": null,
  "pa_number": "EU/1/15/1043/003-004",
  "substances": [
    "Mepolizumab"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "02/08/2019",
  "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 mepolizumab.

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.