France· FR:62036213
ONBREZ BREEZHALER 300 microgrammes, poudre pour inhalation en gélule
A medicinal product containing indacatérol (maléate d'), registered in France by NOVARTIS EUROPHARM (IRLANDE), on the national reimbursement list.
Checked against Base de données publique des médicaments — BDPM (France) on
Informational only — not a medical device.
The record
At a glance
Base de données publique des médicaments — BDPM (France)- Active substance
- INDACATÉROL (MALÉATE D')
- Manufacturer
- NOVARTIS EUROPHARM (IRLANDE)
- Country
- France (FR)
- ATC code
- —
- Reimbursed
- Yes
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 2
1 priced- cip1334009399824651 plaquette(s) thermoformée(s) polyamide aluminium PVC-Aluminium de 10 gélule(s) avec inhalateur(s)
- cip1334009399825263 plaquette(s) thermoformée(s) polyamide aluminium PVC-Aluminium de 10 gélule(s) avec inhalateur(s)EUR 17.65
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Indacatérol (maléate d') 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
- BelgiumAtectura Breezhaler 125 µg - 260 µgNovartis Europharm
- United KingdomOnbrez Breezhaler 150microgram inhalation powder capsules with deviceWaymade Healthcare Plc
- 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
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 Base de données publique des médicaments — BDPM (France). 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/cc1a3527-47ca-4d19-af2e-72ec8a1427d0 GET /v1/drugs/cc1a3527-47ca-4d19-af2e-72ec8a1427d0?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.
{
"cis": "62036213",
"date_amm": "2009-11-30",
"type_amm": "Procédure centralisée",
"numero_ue": "EU/1/09/593",
"substance": "INDACATÉROL (MALÉATE D')",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "poudre pour inhalation en gélule",
"voies_administration": "inhalée",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Non"
}See everything about indacatérol (maléate d').
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.