AusPAR: Pembrolizumab

Australian Public Assessment Report

AusPAR

AusPAR: Pembrolizumab [PDF, 704.88 KB]

AusPAR: Pembrolizumab [Word, 1.38 MB]

Attachment: Product Information: Pembrolizumab [PDF, 633.15 KB]

Attachment: Product Information: Pembrolizumab [Word, 483.41 KB]

Attachment: Extract from Clinical Evaluation: Pembrolizumab [PDF, 7.48 MB]

Attachment: Extract from Clinical Evaluation: Pembrolizumab [Word, 14.64 MB]

Device/Product Name

Keytruda

Active ingredients

Pembrolizumab

AusPAR Date

5 November 2018

Published

18 December 2018

Submission Number

PM-2016-04328-1-4

Submission Type

Extension of indications

Decision

Approved