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AusPAR: Umeclidinium bromide

Australian Public Assessment Report

AusPAR

AusPAR: Umeclidinium bromide [PDF, 2.21 MB]

AusPAR: Umeclidinium bromide [Word, 2.7 MB]

Attachment: Product Information: Umeclidinium bromide [PDF, 395.73 KB]

Attachment: Product Information: Umeclidinium bromide [Word, 309.5 KB]

Attachment: Extract from Clinical Evaluation Report: Umeclidinium bromide [PDF, 5.58 MB]

Attachment: Extract from Clinical Evaluation Report: Umeclidinium bromide [Word, 5.72 MB]

Device/Product Name

Incruse Ellipta

Active ingredients

Umeclidinium bromide

AusPAR Date

9 July 2015

Published

28 July 2015

Submission Number

PM-2013-01505-1-5

Submission Type

New chemical entity

Decision

Approved