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ENERZAIR BREEZHALER (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
ENERZAIR BREEZHALER
Date registered
Evaluation commenced
Decision date
Approval time
226 working days (255)
Active ingredients
glycopyrronium bromide; indacaterol acetate; mometasone furoate
Registration type
EOI
Indication
New Combination
ENERZAIR BREEZHALER (hard capsule) is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.