AusPAR: Insulin glargine

Australian Public Assessment Report

AusPAR

AusPAR: Insulin glargine [PDF, 863.69 KB]

AusPAR: Insulin glargine [Word, 1.57 MB]

Attachment: Product Information: Insulin glargine [PDF, 382.62 KB]

Attachment: Product Information: Insulin glargine [Word, 295.77 KB]

Attachment: Extract from Clinical Evaluation Report: Insulin glargine [PDF, 1.64 MB]

Attachment: Extract from Clinical Evaluation Report: Insulin glargine [Word, 7.44 MB]

Device/Product Name

Abasria / Abasria KwikPen

Active ingredients

Insulin glargine

AusPAR Date

20 August 2015

Published

2 September 2015

Submission Number

PM-2013-02802-1-5

Submission Type

Biosimilar (Insulin analogue)

Decision

Approved