AusPAR: Indacaterol (as acetate) / glycopyrronium (as bromide) / mometasone furoate

Australian Public Assessment Report

AusPAR

AusPAR: Indacaterol (as acetate) / glycopyrronium (as bromide) / mometasone furoate [PDF, 532.67 KB]

AusPAR: Indacaterol (as acetate) / glycopyrronium (as bromide) / mometasone furoate [Word, 476.99 KB]

Attachment: Product Information for Indacaterol (as acetate) / glycopyrronium (as bromide) / mometasone furoate [PDF, 468.3 KB]

Attachment: Product Information for Indacaterol (as acetate) / glycopyrronium (as bromide) / mometasone furoate [Word, 170.84 KB]

Device/Product Name

Enerzair Breezhaler

Active ingredients

Indacaterol (as acetate) / glycopyrronium (as bromide) / mometasone furoate

AusPAR Date

6 April 2021

Published

22 April 2021

Submission Number

PM-2019-02514-1-5

Submission Type

New combination of active ingredients

Decision

Approved