ATECTURA BREEZHALER

This brand name is authorized in Austria, Australia, Canada, Germany, Estonia, Finland, Hong Kong, 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

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