AusPAR: Nintedanib esilate

Australian Public Assessment Report

AusPAR

AusPAR Nintedanib esilate [PDF, 2.18 MB]

AusPAR Nintedanib esilate [DOCX, 4.16 MB]

Attachment: Product Information: Nintedanib esilate (Ofev) [PDF, 356.64 KB]

Attachment: Product Information: Nintedanib esilate (Ofev) [DOCX, 333.06 KB]

Attachment: Product Information: Nintedanib esilate (Vargatef) [PDF, 359.45 KB]

Attachment: Product Information: Nintedanib esilate (Vargatef) [DOCX, 335.37 KB]

Attachment: Extract from Clinical Evaluation Report: Nintedanib esilate [PDF, 3.15 MB]

Attachment: Extract from Clinical Evaluation Report: Nintedanib esilate [DOCX, 8.34 MB]

Device/Product Name

Ofev / Vargatef

Active ingredients

Nintedanib esilate

AusPAR Date

8 February 2016

Published

16 February 2016

Submission Number

PM-2014-01847-1-4

Submission Type

New chemical entity

Decision

Approved

Product types

Prescription medicines