AusPAR: Budesonide / glycopyrronium / formoterol

Australian Public Assessment Report

AusPAR

AusPAR: Budesonide / glycopyrronium / formoterol [PDF, 1.61 MB]

AusPAR: Budesonide / glycopyrronium / formoterol [Word, 5.15 MB]

Attachment: Product information for Budesonide / glycopyrronium / formoterol [PDF, 248.51 KB]

Attachment: Product information for Budesonide / glycopyrronium / formoterol [Word, 135.29 KB]

Device/Product Name

Breztri Aerosphere

Active ingredients

Budesonide / glycopyrronium / formoterol

AusPAR Date

14 April 2022

Published

20 April 2022

Submission Number

PM 2020-02915-1-5

Submission Type

New fixed dose combination

Decision

Approved