Product Dossier
Atectura Breezhaler
Product Dossier for Atectura Breezhaler (indacaterol acetate, mometasone furoate, Novartis Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes,…
- Sponsor: Novartis Pharmaceuticals
- Active ingredient: indacaterol acetate, mometasone furoate
- Therapeutic area: Respiratory
- Related brand: RYALTRIS
- Related brand: Enerzair Breezhaler
- Related brand: ELOCON
- Same area: NUCALA
- Same area: VENTOLIN
What it is
Atectura Breezhaler is a powder for inhalation in hard capsule with inhaler, combining indacaterol acetate and mometasone furoate. Three strengths are registered: 125/62.5 microgram, 125/127.5 microgram, and 125/260 microgram.
Approved indications
— 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 .
Dosing overview
Atectura Breezhaler is administered as a once-daily dose. The three registered strengths allow dosing flexibility based on individual patient requirements.
Key safety warnings
The clinical data supported the efficacy and safety of Atectura Breezhaler, with the benefits outweighing the risks for the proposed indication.
Regulatory history
Atectura Breezhaler was first listed on the ARTG on 21 July 2020. The TGA approved Atectura Breezhaler on 16 July 2020, concluding that its benefits outweigh the risks based on the submitted clinical data and resolved quality and nonclinical aspects. In July 2020, the PBAC recommended Atectura Breezhaler as a new medicine for asthma maintenance treatment.