ATECTURA BREEZHALER

This brand name is authorized in Austria, Australia, Canada, Germany, Estonia, Finland, Hong Kong, Croatia, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, South Africa

Active ingredients

The drug ATECTURA BREEZHALER contains a combination of these active pharmaceutical ingredients (APIs):

1 Indacaterol UNII RYI4401DTM - INDACATEROL ACETATE

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

2 Mometasone UNII 04201GDN4R - MOMETASONE FUROATE

Mometasone is a topical glucocorticoid with local anti-inflammatory properties. It is likely that much of the mechanism for the effects of mometasone lies in its ability to inhibit the release of mediators of the inflammatory cascade. Read about Mometasone

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ATECTURA 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
R03AK14		R Respiratory system → R03 Drugs for obstructive airway diseases → R03A Adrenergics, inhalants → R03AK Adrenergics and other drugs for obstructive airway diseases
Discover more medicines within R03AK14

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): 12269R, 12279G, 12289T
Country: CA	Health Products and Food Branch	Identifier(s): 02498685, 02498693, 02498707
Country: DE	Bundesinstitut für Arzneimittel und Medizinprodukte	Identifier(s): 16384899, 16384913, 16384936, 16384942, 16384971, 16384988, 16384994, 16385019, 16385025, 17396019, 17396025, 17438806, 17562860, 17562877, 17562883, 17628145, 17628151, 17628168, 17635872, 17635932
Country: EE	Ravimiamet	Identifier(s): 1821495, 1821507, 1821518, 1821529, 1821530, 1821541, 1821552, 1821563, 1821574, 1821585, 1821596, 1821608
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 083966, 152408, 183175, 438775, 506788, 578991
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 391146, 391155, 391160
Country: HK	Department of Health Drug Office	Identifier(s): 67120, 67121, 67122
Country: IE	Health Products Regulatory Authority	Identifier(s): 42804, 42805, 42806
Country: JP	医薬品医療機器総合機構	Identifier(s): 2290806G1021, 2290806G2028, 2290806G3024
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1090362, 1090363, 1090364, 1090365, 1090366, 1090367, 1090368, 1090369, 1090371, 1090372, 1090373, 1090374
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 205087, 205109
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100440121, 100440138, 100440144
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W66738001, W66738002, W66739001, W66739002, W66740001, W66740002
Country: ZA	Health Products Regulatory Authority	Identifier(s): 54/10.2.1/0867, 54/10.2.1/0868, 54/10.2.1/0869