Czechia· CZ-0269471
ENERZAIR BREEZHALER
A indacaterol, glycopyrronium bromid und mometason product containing indacaterol acetate + glycopyrronium bromide + mometasone furoate, registered in Czechia by Novartis Europharm Limited, Dublin. The same ATC class is registered in 11 of our 19 countries.
Checked against SÚKL (Czech Republic) on
Informational only — not a medical device.
Where it is registered
Indacaterol, glycopyrronium bromid und mometason is registered in 11 of 19 countries.
Countries holding a registration under ATC R03AL12 (indacaterol, glycopyrronium bromid und mometason), each read from that country’s own register.
- This record: Czechia, from SÚKL (Czech Republic)
- 7 of them publish a price we can compare per daily dose
Indacaterol, glycopyrronium bromid und mometason · ATC R03AL12
11 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
The record
At a glance
SÚKL (Czech Republic)- Active substance
- INDACATEROL ACETATE + GLYCOPYRRONIUM BROMIDE + MOMETASONE FUROATE
- Manufacturer
- Novartis Europharm Limited, Dublin
- Country
- Czechia (CZ)
- ATC code
- R03AL12
- ATC class
- Indacaterol, Glycopyrronium bromid und Mometason
- Reimbursed
- Not published by this register
- Source register
- SÚKL (Czech Republic)
- Last checked
- September 28, 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, glycopyrronium bromid und mometason in 5 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandEnerzair BreezhalerNovartis Europharm Limited
- IrelandEnerzair Breezhaler 114 micrograms/46 micrograms/136 micrograms inhalation powder, hard capsulesNovartis Europharm Limited
- SwedenEnerzair Breezhaler 114 mikrogram/46 mikrogram/136 mikrogram Inhalationspulver, hård kapselNovartis Europharm Limited
- United KingdomEnerzair Breezhaler 114micrograms/dose / 46micrograms/dose / 136micrograms/dose inhalation powder capsules with deviceNovartis Pharmaceuticals UK Ltd
- NorwayEnerzair BreezhalerNovartis Europharm Limited (1)
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Enerzair Breezhaler, Zimbus Breezhaler
- Liechtenstein · Enerzair Breezhaler, Zimbus Breezhaler
- Norway · Enerzair Breezhaler, Zimbus Breezhaler
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 SÚKL (Czech Republic). 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/c74db9a2-e41b-40d3-b035-af6c35ccbc3c GET /v1/drugs/c74db9a2-e41b-40d3-b035-af6c35ccbc3c?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": "INH PLV CPS DUR",
"source": "sukl",
"strength": "114MCG/46MCG/136MCG",
"pack_size": "30X1+1INH",
"substance": "INDACATEROL ACETATE + GLYCOPYRRONIUM BROMIDE + MOMETASONE FUROATE",
"cz_kod_sukl": "0269471",
"product_type": "CH",
"substance_codes": "22558,4842,9992",
"registration_state": "R",
"registration_number": "EU/1/20/1438/002"
}See everything about indacaterol, glycopyrronium bromid und mometason.
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.