AusPAR: Glycopyrronium (as bromide)

Australian Public Assessment Report

AusPAR

AusPAR: Glycopyrronium (as bromide) [PDF, 3.34 MB]

AusPAR: Glycopyrronium (as bromide) [Word, 3.45 MB]

Attachment: Product Information: Glycopyrronium (as bromide) [PDF, 289.19 KB]

Attachment: Product Information: Glycopyrronium (as bromide) [Word, 288.1 KB]

Attachment: Extract from Clinical Evaluation Report: Glycopyrronium (as bromide) [PDF, 7.85 MB]

Attachment: Extract from Clinical Evaluation Report: Glycopyrronium (as bromide) [Word, 7.1 MB]

Device/Product Name

Seebri Breezhaler / Tovanor Breezhaler

Active ingredients

Glycopyrronium (as bromide)

AusPAR Date

10 July 2013

Published

9 October 2013

Submission Number

PM-2011-02800-3-5

Submission Type

New chemical entity

Decision

Approved