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Ireland· IE-PA-EU/1/13/862/001-006

Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

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

ATC R03AL04

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedUltibro Breezhaler 85 micrograms/43 m…ATCR03AL04REGISTER NO.IE-PA-EU/1/13/862/001…PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about indacaterol maleate + glycopyrronium bromideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

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

Countries holding a registration under ATC R03AL04 (indacaterol und glycopyrronium bromid), 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 und glycopyrronium bromid products by name

Indacaterol und glycopyrronium bromid · ATC R03AL04

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 maleate + Glycopyrronium bromide
Manufacturer
Novartis Europharm Limited
Country
Ireland (IE)
ATC code
R03AL04
ATC class
Indacaterol und Glycopyrronium bromid
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/13/862/001-006

Regulatory notes

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

Same medicine, other countries

Indacaterol und glycopyrronium bromid in 5 other countries

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

All indacaterol und glycopyrronium bromid products

Authorised across Europe · EMA

The same active substance is authorised in 17 EEA countries. Names it is sold under:

  • Belgium · Indacaterol/Glycopyrronium Eg
  • Czechia · Amidil Combi Amihaler
  • Germany · Indacaterol/Glycopyrronium Al, Indacaterol/Glycopyrronium Stada
  • Denmark · Copdalan, Indacaterol/Glycopyrronium Genetic
  • Finland · Indacaterol/Glycopyrronium Stada
  • France · Indacaterol/Glycopyrronium Axica Biogaran, Indacaterol/Glycopyrronium Rs01 Inhaler Arrow
  • Greece · Indacaterol Glycopyrronium Stada, Libair
  • Croatia · Indakaterol/Glikoprionij Stada
  • Iceland · Plungymed, Ultibro Breezhaler
  • Italy · Glindesia
  • Liechtenstein · Ultibro Breezhaler, Ulunar Breezhaler
  • Netherlands · Indacaterol Glycopyrronium Stada
  • Norway · Indacaterol/Glycopyrronium Stada, Plungymed
  • Poland · Amidil Combo Amihaler
  • Portugal · Brometo De Glicopirrónio + Indacaterol Generis, Brometo De Glicopirrónio + Indacaterol Stada
  • Sweden · Copdalan, Indacaterol/Glycopyrronium Polpharma
  • Slovakia · Amidil Combi Amihaler

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/c8f06b31-9d23-4f77-8298-eae1d03cf493
GET /v1/drugs/c8f06b31-9d23-4f77-8298-eae1d03cf493?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": [
    "R03AL",
    "R03AL04"
  ],
  "strength": null,
  "pa_number": "EU/1/13/862/001-006",
  "substances": [
    "Indacaterol maleate",
    "Glycopyrronium bromide"
  ],
  "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "19/09/2013",
  "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

See everything about indacaterol und glycopyrronium bromid.

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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