BREZTRI AEROSPHERE (AstraZeneca Pty Ltd)
Product name
BREZTRI AEROSPHERE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
196 (255 working days)
Active ingredients
budesonide; formoterol (eformoterol) fumarate dihydrate; glycopyrronium bromide (glycopyrrolate)
Registration type
EOI
Indication
New combination
BREZTRI AEROSPHERE (pressurised metered dose inhaler) is indicated for maintenance treatment to prevent exacerbations and relieve symptoms in adults with moderate, severe, or very severe chronic obstructive pulmonary disease (COPD) who require treatment with a combination of an inhaled corticosteroid (ICS), a long-acting Î’2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA).
BREZTRI AEROSPHERE 160/7.2/5 is not indicated for the initiation of therapy in COPD.