AusPAR: Pirfenidone

Australian Public Assessment Report

AusPAR

AusPAR: Pirfenidone [PDF, 1.19 MB]

AusPAR: Pirfenidone [Word, 1.2 MB]

Attachment: Product Information: Pirfenidone [PDF, 244.33 KB]

Attachment: Product Information: Pirfenidone [Word, 86.55 KB]

Attachment: Extract from Clinical Evaluation Report: Pirfenidone [PDF, 1.87 MB]

Attachment: Extract from Clinical Evaluation Report: Pirfenidone [Word, 2.76 MB]

Device/Product Name

Esbriet

Active ingredients

Pirfenidone

AusPAR Date

9 August 2016

Published

29 August 2016

Submission Number

PM-2015-00413-1-5

Submission Type

New chemical entity

Decision

Approved