ONBREZ BREEZHALER

This brand name is authorized in Austria, Australia, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa

Active ingredients

The drug ONBREZ BREEZHALER contains one active pharmaceutical ingredient (API):

1 Indacaterol UNII 2JEC1ITX7R - INDACATEROL MALEATE

Indacaterol is a partial agonist at the human beta2-adrenergic receptor with nanomolar potency. When inhaled, indacaterol acts locally in the lung as a bronchodilator. In isolated human bronchus, indacaterol has a rapid onset of action and a long duration of action. Read about Indacaterol

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ONBREZ BREEZHALER Inhalation powder, hard capsule	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
R03AC18	Indacaterol	R Respiratory system → R03 Drugs for obstructive airway diseases → R03A Adrenergics, inhalants → R03AC Selective beta-2-adrenoreceptor agonists
Discover more medicines within R03AC18

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 5134F, 5137J
Country: CA	Health Products and Food Branch	Identifier(s): 02376938
Country: DE	Bundesinstitut für Arzneimittel und Medizinprodukte	Identifier(s): 05742491, 05742516, 06424480, 06424497, 06573814, 07550057, 07550063, 07713594, 07713654, 07769904, 07769927, 08794407, 09060587, 09488492, 11525131, 12739029, 12739041, 12739058, 16626032, 16626049, 17936970
Country: EE	Ravimiamet	Identifier(s): 1452158, 1452169, 1452170, 1452181, 1452192, 1452204, 1452215, 1452226, 1452237, 1452248
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 09593002, 09593007
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 075031, 075042, 075064, 075075
Country: FR	Base de données publique des médicaments	Identifier(s): 62036213, 67084265
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 173000, 173009, 375263, 375268, 381572, 381574
Country: HK	Department of Health Drug Office	Identifier(s): 60179, 60180
Country: IE	Health Products Regulatory Authority	Identifier(s): 37611, 37612, 37635, 37636, 42843, 42891
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6656, 6657
Country: IT	Agenzia del Farmaco	Identifier(s): 039664014, 039664026, 039664038, 039664040, 039664053, 039664065, 039664077, 039664089, 039664091, 039664103
Country: JP	医薬品医療機器総合機構	Identifier(s): 2259710G1020
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1052400, 1052401, 1052402, 1052403, 1052404, 1052405, 1052406, 1052407, 1052408, 1052409
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 92347, 92355
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 14709, 14710
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100217883, 100217890
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64463001, W64463002, W64463003, W64463004, W64463005, W64464001, W64464002, W64464003, W64464004, W64464005
Country: SG	Health Sciences Authority	Identifier(s): 13988P, 13989P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 10283331
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699504550405, 8699504550450
Country: ZA	Health Products Regulatory Authority	Identifier(s): 44/10.2.1/0544