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BREZTRI AEROSPHERE 160/14.4/5 AstraZeneca Pty Ltd
Product name
BREZTRI AEROSPHERE 160/14.4/5
Sponsor
Accepted date
Sep-2025
Active ingredients
budesonide, formoterol fumarate dihydrate, glycopyrronium bromide
Proposed indication
Breztri Aerosphere 160/14.4/5 (budesonide) is proposed for the maintenance treatment of asthma and to prevent worsening asthma in patients 12 years of age and older.
Application type
C (new indication)
Publication date
Sep-2025