Belgium· BE-AMP-SAM666226-00
Indacaterol/Glycopyrronium EG 85 µg - 43 µg
A indacaterol und glycopyrronium bromid product containing indacaterol maleate, registered in Belgium by EG. The same ATC class is registered in 11 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) 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: Belgium, from FAMHP / AFMPS (Belgium)
- 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
FAMHP / AFMPS (Belgium)- Active substance
- Indacaterol Maleate
- Manufacturer
- EG
- Country
- Belgium (BE)
- ATC code
- R03AL04
- ATC class
- Indacaterol und Glycopyrronium bromid
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 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 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaHIROBRIZ BREEZHALERNovartis Europharm Limited, Dublin
- SpainHIROBRIZ BREEZHALER 150 microgramos POLVO PARA INHALACION (CAPSULA DURA)Novartis Europharm Limited
- United KingdomOnbrez Breezhaler 150microgram inhalation powder capsules with deviceCST Pharma Ltd
- IcelandHirobriz BreezhalerNovartis Europharm Limited*
- SwedenHirobriz Breezhaler 150 mikrogram Inhalationspulver, hård kapselNovartis Europharm Limited
- SwitzerlandOnbrez Breezhaler 150 mcg, Pulver Hartkapseln zur Inhalation (mit Inhalator)Novartis Pharma Schweiz AG
- FinlandHirobriz BreezhalerNovartis Europharm Limited
- IrelandHirobriz Breezhaler 150 microgram inhalation powder, hard capsulesNovartis Europharm Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Hirobriz Breezhaler, Onbrez Breezhaler
- Liechtenstein · Hirobriz Breezhaler, Onbrez Breezhaler
- Norway · Hirobriz Breezhaler, Onbrez 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 FAMHP / AFMPS (Belgium). 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/070d4550-7dbc-4f38-bd19-2bd100acced3 GET /v1/drugs/070d4550-7dbc-4f38-bd19-2bd100acced3?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": "Inhalation powder, hard capsule",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Indacaterol/Glycopyrronium EG 85 µg - 43 µg",
"name_fr": "Indacaterol/Glycopyrronium EG 85 µg - 43 µg",
"name_nl": "Indacaterol/Glycopyrronium EG 85 µg - 43 µg",
"amp_code": "SAM666226-00",
"strengths": [
"0.1430",
"0.1430",
"0.1100",
"0.1100",
"0.0630",
"0.0630",
"0.0500",
"0.0500",
"24.6450"
],
"pack_count": 3,
"substances": [
"Indacaterol Maleate",
"Indacaterol",
"Glycopyrronium Bromide",
"Glycopyrronium",
"Lactose Monohydrate"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Indacaterol and Glycopyrronium Bromide",
"authorisation_numbers": [
"BE666226"
]
}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.