AusPAR: Imatinib (as mesylate)

Australian Public Assessment Report

AusPAR

AusPAR: Imatinib (as mesylate) [PDF, 748.55 KB]

AusPAR: Imatinib (as mesylate) [Word, 1.23 MB]

Attachment: Product Information: Imatinib (as mesylate) [PDF, 722.24 KB]

Attachment: Product Information: Imatinib (as mesylate) [Word, 982.21 KB]

Attachment: Extract from Clinical Evaluation Report: Imatinib (as mesylate) [PDF, 2.19 MB]

Attachment: Extract from Clinical Evaluation Report: Imatinib (as mesylate) [Word, 2.4 MB]

Device/Product Name

Glivec

Active ingredients

Imatinib (as mesylate)

AusPAR Date

4 June 2013

Published

11 July 2013

Submission Number

PM-2011-02797-3-4

Submission Type

Major variation (extension of duration of treatment)

Decision

Approved