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Netherlands· NL-485022c7567d

Ultibro Breezhaler 85 microgram/43 microgram inhalatiepoeder in harde capsules

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

ATC R03AL04

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedUltibro Breezhaler 85 microgram/43 mi…ATCR03AL04REGISTER NO.NL-485022c7567dPACKS LISTED1CHECKEDSeptember 29, 2026

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: Netherlands, from CBG-MEB (Netherlands)
  • 7 of them publish a price we can compare per daily dose

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

CBG-MEB (Netherlands)
Active substance
GLYCOPYRRONIUMBROMIDE + INDACATEROLMALEAAT
Manufacturer
Novartis Europharm Limited
Country
Netherlands (NL)
ATC code
R03AL04
ATC class
Indacaterol und Glycopyrronium bromid
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/13/862

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 CBG-MEB (Netherlands). 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/bc1e039b-46e5-452d-a3df-b35a4e85d1b2
GET /v1/drugs/bc1e039b-46e5-452d-a3df-b35a4e85d1b2?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": "Inhalatiepoeder in harde capsule",
  "route": "Inhalatie",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/ultibro-breezhaler-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Indacaterol and glycopyrronium bromide",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp112896",
  "excipients": [
    "AMMONIA (E 527)",
    "BLAUWE INKT",
    "CALCIUMCHLORIDE 2-WATER (E 509)",
    "HYPROMELLOSE (E 464)",
    "IJZEROXIDE ZWART (E 172)",
    "INDIGOKARMIJN ALUMINIUMLAK (E 132)",
    "KALIUMHYDROXIDE (E 525)",
    "LACTOSE 1-WATER",
    "MAGNESIUMSTEARAAT (E 470b)",
    "PROPYLEENGLYCOL (E 1520)",
    "SCHELLAK (E 904)",
    "SCHELLAK (E 904)",
    "TARTRAZINE (E 102)",
    "TITAANDIOXIDE (E 171)",
    "ZWARTE INKT"
  ],
  "substances": [
    "GLYCOPYRRONIUMBROMIDE",
    "INDACATEROLMALEAAT"
  ],
  "leaflet_url": null,
  "authorised_at": "2013/09/19",
  "procedure_number": "EMEA/H/C/002679",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/13/862",
  "additional_monitoring": "N"
}

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.