AusPAR: Umeclidinium bromide and Vilanterol trifenatate

Australian Public Assessment Report

AusPAR

AusPAR: Umeclidinium bromide and Vilanterol trifenatate [PDF, 1.25 MB]

AusPAR: Umeclidinium bromide and Vilanterol trifenatate [DOCX, 1.24 MB]

Attachment: Product Information: Umeclidinium bromide and Vilanterol trifenatate [PDF, 342.67 KB]

Attachment: Product Information: Umeclidinium bromide and Vilanterol trifenatate [DOCX, 321.05 KB]

Attachment: Extract from the Clinical Evaluation Report: Umeclidinium bromide and Vilanterol trifenatate [PDF, 2.76 MB]

Attachment: Extract from the Clinical Evaluation Report: Umeclidinium bromide and Vilanterol trifenatate [DOCX, 4.36 MB]

Device/Product Name

Anoro Ellipta

Active ingredients

Umeclidinium bromide and Vilanterol trifenatate

AusPAR Date

8 April 2015

Published

25 June 2015

Submission Number

PM-2013-00332-1-5

Submission Type

New fixed dose combination

Decision

Approved

Product types

Prescription medicines