Product Dossier
Breztri Aerosphere
Product Dossier for Breztri Aerosphere (budesonide, AstraZeneca). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: AstraZeneca
- Active ingredient: budesonide
- Therapeutic area: Respiratory
- Related brand: PULMICORT
- Related brand: BUDENOFALK
- Related brand: JORVEZA
- Same area: NUCALA
- Same area: VENTOLIN
What it is
BREZTRI AEROSPHERE is an inhalation pMDI (pressurised metered-dose inhaler) containing budesonide 160 micrograms, glycopyrronium 7.2 micrograms, and formoterol fumarate dihydrate 5 micrograms per actuation.
Approved indications
— 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 β2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA). BREZTRI AEROSPHERE is not indicated for the initiation of therapy in COPD.
Regulatory history
BREZTRI AEROSPHERE was first listed on the ARTG on 19 July 2021. The AusPAR (Australian Public Assessment Report) approval date was 16 July 2021. The PBAC recommended the medicine in July 2021 for moderate to severe chronic obstructive pulmonary disease, and again in November 2022 for chronic obstructive pulmonary disease. A second variant with DFP-EvoCap technology was registered on 11 August 2022, and a third variant on 10 April 2026.