AusPAR: Insulin degludec (rys)

Australian Public Assessment Report

AusPAR

AusPAR: Insulin degludec (rys) [PDF, 1.11 MB]

AusPAR: Insulin degludec (rys) [Word, 2.41 MB]

Attachment: Product Information: Insulin degludec (rys) [PDF, 389.88 KB]

Attachment: Product Information: Insulin degludec (rys) [Word, 251.94 KB]

AusPAR Attachment 2 Extract from the Clinical Evaluation Report for insulin degludec (rys) [PDF, 2.26 MB]

Attachment: Extract from Clinical Evaluation Report: Insulin degludec (rys) [Word, 4.46 MB]

Device/Product Name

Tresiba FlexTouch; Tresiba Penfill

Active ingredients

Insulin degludec (rys)

AusPAR Date

22 May 2018

Published

26 June 2018

Submission Number

PM-2016-02721-1-5

Submission Type

New chemical entity

Decision

Approved