AusPAR: Insulin detemir (rys)

Australian Public Assessment Report

AusPAR

AusPAR: Insulin detemir (rys) [PDF, 829.72 KB]

AusPAR: Insulin detemir (rys) [Word, 1.34 MB]

Attachment: Product Information: Insulin detemir (rys) [PDF, 323.05 KB]

Attachment: Product Information: Insulin detemir (rys) [Word, 325.38 KB]

Attachment: Extract from Clinical Evaluation Report: Insulin detemir (rys) [PDF, 3.52 MB]

Attachment: Extract from Clinical Evaluation Report: Insulin detemir (rys) [Word, 7.29 MB]

Device/Product Name

Levemir

Active ingredients

Insulin detemir (rys)

AusPAR Date

28 March 2014

Published

1 June 2014

Submission Number

PM-2012-02256-3-5

Submission Type

Major variation (change in patient group/pregnancy category)

Decision

Approved