Iceland· IS-EU/1/13/862/001-008
Ultibro Breezhaler
A indacaterol und glycopyrronium bromid product containing indacaterolum inn maleat,glycopyrronii bromidum inn, registered in Iceland by Novartis Europharm Limited*. The same ATC class is registered in 11 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) 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: Iceland, from Icelandic Medicines Agency (Iceland)
- 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
Icelandic Medicines Agency (Iceland)- Active substance
- Indacaterolum INN maleat,Glycopyrronii bromidum INN
- Manufacturer
- Novartis Europharm Limited*
- Country
- Iceland (IS)
- ATC code
- R03AL04
- ATC class
- Indacaterol und Glycopyrronium bromid
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 2026
Packs & prices · 0
No packs listed by the register for this record.
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.
- NetherlandsDILABRO 85 microgram/43 microgram inhalatiepoeder in harde capsulesS.F Group S.r.l.
- 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 Icelandic Medicines Agency (Iceland). 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/8fad7e92-63e7-46b9-a39f-3fcc7bd850ff GET /v1/drugs/8fad7e92-63e7-46b9-a39f-3fcc7bd850ff?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": "Innöndunarduft, hart hylki",
"source": "lyfjastofnun",
"atc_raw": "R03AL04",
"marketed": false,
"strength": "85 míkróg/43 míkróg",
"ma_number": "EU/1/13/862/001-008",
"substance": "Indacaterolum INN maleat,Glycopyrronii bromidum INN",
"other_info": null,
"legal_status": "(R) Lyfseðilsskylt",
"ma_issued_serial": "41536"
}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.