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.
Checked against CBG-MEB (Netherlands) on
Informational only — not a medical device.
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
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_idEU/1/13/862
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.
- SpainPOUPOX 85 MICROGRAMOS/43 MOCROGRAMOS POLVO PARA INHALACION (CAPSULA DURA)Laboratorios Liconsa S.A.
- IcelandPlungymedMedical Valley Invest AB
- PolandAmidil Combo AmiHalerZakłady Farmaceutyczne POLPHARMA S.A.
- SwitzerlandUltibro Breezhaler 110/50, Hartkapseln mit Pulver zur InhalationNovartis Pharma Schweiz AG
- CanadaULTIBRO BREEZHALERNOVARTIS PHARMACEUTICALS CANADA INC
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.