BUDESONIDE WITH GLYCOPYRRONIUM AND FORMOTEROL

Information current as at: 1 September 2026

PBAC meeting date: July 2026
Legend: Completed N In progress Not applicable N Yet to commence

Submission Details

Brand name:
  • Breztri Aerosphere®
Form and strength:
  • Pressurised inhalation containing budesonide 160 micrograms with glycopyrronium 14.4 micrograms and formoterol fumarate dihydrate 5 micrograms per dose, 120 doses
Submission sponsor:
ASTRAZENECA PTY LTD
Condition/indication:
(therapeutic use)
  • Severe asthma
Listing requested:
To request listing of a new form of budesonide with glycopyrronium and formoterol for the maintenance treatment of severe asthma in adult patients not adequately controlled with a maintenance combination of a long‑acting beta agonist (LABA) and an inhaled corticosteroid (ICS) who experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma.
Funding program:
PBS General Schedule
Request authority level:
Authority Required (STREAMLINED)
PBAC Submission type:
New PBS listing (–)
Comment:
To be considered at a future PBAC meeting
Other PBAC consideration:

Progress Details

Submission received for:
July 2026 PBAC meeting
Opportunity for consumer comment:
Open 25/03/2026 and close 20/05/2026 (see PBS Website)
PBAC meeting:
Not applicable
PBAC outcome published:
Not Applicable (see PBAC Outcomes)
Lodgement of required documentation:
Not applicable
Agreement to listing arrangements:
Not applicable
Government processes:
Not applicable
Medicine listed on the PBS:
Not applicable
Glossary

PBAC Outcome

PBAC Recommendation:
Please see the Outcomes from the relevant meeting for more information
Case ID
1218
Page last updated
31 August 2026
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