BREZTRI AEROSPHERE (AstraZeneca Pty Ltd)
Product name
BREZTRI AEROSPHERE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
188 (255 working days)
Active ingredients
budesonide, formoterol fumarate dihydrate, glycopyrronium bromide
Registration type
EOI
Indication
Asthma
Maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled with a combination of a medium or high dose inhaled corticosteroid and a long-acting β2-agonist.