ATECTURA BREEZHALER (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
ATECTURA BREEZHALER
Date registered
Evaluation commenced
Decision date
Approval time
194 working days (255)
Active ingredients
indacaterol acetate; mometasone furoate
Registration type
EOI
Indication
New Combination
ATECTURA BREEZHALER (microgram powder for inhalation in hard capsule with inhaler) is indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older where use of a combination of long-acting beta2-agonist and inhaled corticosteroid is appropriate:
- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting beta2-agonists or
- patients not adequately controlled with long-acting beta2-agonists and low dose of inhaled corticosteroids and 'as needed' inhaled short-acting beta2-agonists.