BUDESONIDE WITH GLYCOPYRRONIUM AND FORMOTEROL
Information current as at: 1 September 2026
PBAC meeting date: September 2026
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) -
- To consider a request for 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.
- Listing requested:
- Please see PSD for more information
- Funding program:
- PBS General Schedule
- Request authority level:
- Authority Required (STREAMLINED)
- PBAC Submission type:
- New PBS listing (Category 2)
- Comment:
- --
- Other PBAC consideration:
Progress Details
-
Submission received for: - September 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 25/03/2026 and close 20/05/2026 (see PBS Website)
-
3PBAC meeting:
- Has not yet occurred
-
4PBAC outcome published:
- Pending PBAC outcome (see PBAC Outcomes)
-
5Lodgement of required documentation:
- Has not yet commenced
-
6Agreement to listing arrangements:
- Has not yet commenced
-
7Government processes:
- Has not yet commenced
-
8Medicine listed on the PBS:
- Has not yet occurred
PBAC Outcome
Case ID
a1320
Page last updated
31 August 2026
v.9.19