Czechia· CZ-0249768
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 · 1
1 priced- cz_kod_sukl024976830X1+1INH+1SENZORCZK 1748.55
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/d921a10c-177e-47dc-803e-9be7fd998624 GET /v1/drugs/d921a10c-177e-47dc-803e-9be7fd998624?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+1SENZOR",
"substance": "INDACATEROL ACETATE + GLYCOPYRRONIUM BROMIDE + MOMETASONE FUROATE",
"cz_kod_sukl": "0249768",
"product_type": "CH",
"substance_codes": "22558,4842,9992",
"registration_state": "R",
"registration_number": "EU/1/20/1438/003"
}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.