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AusPAR: Tiotropium bromide

Australian Public Assessment Report

AusPAR

AusPAR Tiotropium bromide [PDF, 2.57 MB]

AusPAR Tiotropium bromide [Word, 5.49 MB]

Attachment: Product Information: Tiotropium bromide [PDF, 265.18 KB]

Attachment: Product Information: Tiotropium bromide [Word, 81.75 KB]

Attachment: Product Information: Tiotropium bromide [PDF, 251.3 KB]

Attachment: Product Information: Tiotropium bromide [Word, 81.13 KB]

Attachment: Extract from Clinical Evaluation Report: Tiotropium bromide [PDF, 4.44 MB]

Attachment: Extract from Clinical Evaluation Report: Tiotropium bromide [Word, 5.49 MB]

Device/Product Name

Spiriva Respimat / Favint Respimat

Active ingredients

Tiotropium bromide

AusPAR Date

25 November 2016

Published

29 November 2016

Submission Number

PM-2014-00350-1-5

Submission Type

Extension of indications

Decision

Approved