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FOSTAIR (Emerge Health Pty Ltd)
Product name
FOSTAIR
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
194 working days (255)
Active ingredients
beclometasone dipropionate; formoterol (eformoterol) fumarate dihydrate
Registration type
EOI
Indication
New Combination
Asthma
FOSTAIR (solution for inhalation) is indicated in adults (18 years and older) in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate:
- patients not adequately controlled with inhaled corticosteroids (ICS) and 'as needed' inhaled rapid-acting beta2-agonist or
- patients already adequately controlled on both ICS and long-acting beta2-agonists (LABA).
COPD
Symptomatic treatment of adults with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.