ATECTURA BREEZHALER

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

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 more 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 more about Mometasone

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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