Poland· PL-100313500
Xoterna Breezhaler
A indacaterol und glycopyrronium bromid product containing indacaterolum + glycopyrronii bromidum, registered in Poland by Novartis Europharm Limited. The same ATC class is registered in 11 of our 19 countries.
Checked against URPL (Poland) 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: Poland, from URPL (Poland)
- 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
URPL (Poland)- Active substance
- Indacaterolum + Glycopyrronii bromidum
- Manufacturer
- Novartis Europharm Limited
- Country
- Poland (PL)
- ATC code
- R03AL04
- ATC class
- Indacaterol und Glycopyrronium bromid
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 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.
- IcelandPlungymedMedical Valley Invest AB
- 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 URPL (Poland). 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/d894f2e1-5962-4e9a-aeda-2bfe544ee785 GET /v1/drugs/d894f2e1-5962-4e9a-aeda-2bfe544ee785?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": "Proszek do inhalacji w kapsułkach twardych",
"source": "urpl",
"strength": "(85 mcg + 43 mcg)/dawkę",
"packaging": "Rp ¦ EU/1/13/863/001 ¦ 90484\n6 kaps. ¦ 1 inhalator \nRp ¦ EU/1/13/863/002 ¦ 90485\n12 kaps. ¦ 1 inhalator \nRp ¦ EU/1/13/863/003 ¦ 90486\n30 kaps. ¦ 1 inhalator \nRp ¦ EU/1/13/863/004 ¦ 90487\n90 kaps. ¦ 1 inhalator \nRp ¦ EU/1/13/863/005 ¦ 90488\n96 kaps. ¦ 4 inhalatory \nRp ¦ EU/1/13/863/006 ¦ 90489\n150 kaps. ¦ 25 inhalatorów \nRp ¦ EU/1/13/863/007 ¦ 122117\n10 kaps. ¦ 1 inhalator \nRp ¦ EU/1/13/863/008 ¦ 122118\n150 kaps. ¦ 15 inhalatorów",
"substance": "Indacateroli maleas 110 mcg/dawkę + Glycopyrronii bromidum 54 mcg/dawkę",
"common_name": "Indacaterolum + Glycopyrronii bromidum",
"pl_product_id": "100313500",
"pozwolenie_nr": null,
"auth_procedure": "CEN",
"authorisation_validity": null
}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.