AusPAR: Indacaterol maleate/ Glycopyrronium bromide

Australian Public Assessment Report

AusPAR

AusPAR: Indacaterol maleate/ Glycopyrronium bromide [PDF, 754.65 KB]

AusPAR: Indacaterol maleate/ Glycopyrronium bromide [Word, 2.03 MB]

Attachment: Product Information: Indacaterol maleate/ Glycopyrronium bromide [PDF, 426.33 KB]

Attachment: Product Information: Indacaterol maleate/ Glycopyrronium bromide [Word, 396.72 KB]

Attachment: Extract from Clinical Evaluation: Indacaterol maleate/ Glycopyrronium bromide [PDF, 1.06 MB]

Attachment: Extract from Clinical Evaluation: Indacaterol maleate/ Glycopyrronium bromide [Word, 3.84 MB]

Device/Product Name

Ultibro Breezhaler

Active ingredients

Indacaterol maleate/ Glycopyrronium bromide

AusPAR Date

3 September 2018

Published

2 October 2018

Submission Number

PM-2016-02734-1-5

Submission Type

Major variation extension of indications

Decision

Approved