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Ireland· IE-PA-EU/1/20/1438/001-005

Enerzair Breezhaler 114 micrograms/46 micrograms/136 micrograms inhalation powder, hard capsules

A indacaterol, glycopyrronium bromid und mometason product containing indacaterol acetate + glycopyrronium bromide + mometasone furoate, registered in Ireland by Novartis Europharm Limited. The same ATC class is registered in 11 of our 19 countries.

ATC R03AL12

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedEnerzair Breezhaler 114 micrograms/46…ATCR03AL12REGISTER NO.IE-PA-EU/1/20/1438/00…PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about indacaterol acetate + glycopyrronium bromide + mometasone furoateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Indacaterol, glycopyrronium bromid und mometason is registered in 11 of 19 countries.

Countries holding a registration under ATC R03AL12 (indacaterol, glycopyrronium bromid und mometason), 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 indacaterol, glycopyrronium bromid und mometason products by name

Indacaterol, glycopyrronium bromid und mometason · ATC R03AL12

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
Indacaterol acetate + Glycopyrronium bromide + Mometasone furoate
Manufacturer
Novartis Europharm Limited
Country
Ireland (IE)
ATC code
R03AL12
ATC class
Indacaterol, Glycopyrronium bromid und Mometason
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/20/1438/001-005

Regulatory notes

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

Same medicine, other countries

Indacaterol, glycopyrronium bromid und mometason in 5 other countries

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

All indacaterol, glycopyrronium bromid und mometason products

Authorised across Europe · EMA

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

  • Iceland · Enerzair Breezhaler, Zimbus Breezhaler
  • Liechtenstein · Enerzair Breezhaler, Zimbus Breezhaler
  • Norway · Enerzair Breezhaler, Zimbus Breezhaler

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/73ff8285-8f90-4f12-ad11-f904eb31b5d5
GET /v1/drugs/73ff8285-8f90-4f12-ad11-f904eb31b5d5?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": "Inhalation powder, hard capsule",
  "routes": [
    "Inhalation use"
  ],
  "source": "hpra",
  "atc_all": [
    "R03AL12"
  ],
  "strength": null,
  "pa_number": "EU/1/20/1438/001-005",
  "substances": [
    "Indacaterol acetate",
    "Glycopyrronium bromide",
    "Mometasone furoate"
  ],
  "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "03/07/2020",
  "dispensing_status": "Product subject to prescription which may be renewed (B)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}
API referenceMCP serverPlans

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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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