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AusPAR: Fluticasone furoate / umeclidinium / vilanterol

Australian Public Assessment Report

AusPAR

AusPAR: Fluticasone furoate / umeclidinium / vilanterol [PDF, 472.31 KB]

AusPAR: Fluticasone furoate / umeclidinium / vilanterol [DOCX, 707.9 KB]

Attachment: Product Information for Fluticasone furoate / umeclidinium / vilanterol [PDF, 676.78 KB]

Attachment: Product Information for Fluticasone furoate / umeclidinium / vilanterol [DOCX, 1.18 MB]

Device/Product Name

Trelegy Ellipta

Active ingredients

Fluticasone furoate / umeclidinium / vilanterol

AusPAR Date

8 September 2021

Published

30 September 2021

Submission Number

PM-2020-01842-1-5

Submission Type

Extension of indications and major variation (new strength)

Decision

Approved

Product types

Prescription medicines