AusPAR: Indacaterol maleate / Glycopyrronium bromide

Australian Public Assessment Report

AusPAR

AusPAR: Indacaterol maleate / Glycopyrronium bromide [PDF, 1.14 MB]

AusPAR: Indacaterol maleate / Glycopyrronium bromide [DOCX, 1.39 MB]

Attachment: Product information: Indacaterol maleate / Glycopyrronium bromide [PDF, 353.67 KB]

Attachment: Product information: Indacaterol maleate / Glycopyrronium bromide [DOCX, 378.47 KB]

Attachment: Extract from the Clinical Evaluation Report: Indacaterol maleate / Glycopyrronium bromide [PDF, 1.23 MB]

Attachment: Extract from the Clinical Evaluation Report: Indacaterol maleate / Glycopyrronium bromide [DOCX, 1.5 MB]

Device/Product Name

Ultibro Breezhaler 110/50

Active ingredients

Indacaterol maleate / Glycopyrronium bromide

AusPAR Date

23 October 2014

Published

20 November 2014

Submission Number

PM-2012-04395-1-5

Submission Type

New combination of active ingredients

Decision

Approved

Product types

Prescription medicines