AusPAR: Pembrolizumab (rch)

Australian Public Assessment Report

AusPAR

AusPAR: Pembrolizumab (rch) [PDF, 1.59 MB]

AusPAR: Pembrolizumab (rch) [Word, 2.77 MB]

Attachment: Product Information: Pembrolizumab (rch) [PDF, 510.21 KB]

Attachment: Product Information: Pembrolizumab (rch) [Word, 410.96 KB]

Attachment: Extract from Clinical Evaluation Pembrolizumab (rch) [PDF, 3 MB]

Attachment: Extract from Clinical Evaluation Pembrolizumab (rch) [Word, 6.17 MB]

Attachment: Extract from Clinical Evaluation Pembrolizumab (rch) [PDF, 2.47 MB]

Attachment: Extract from Clinical Evaluation Pembrolizumab (rch) [Word, 6.35 MB]

Device/Product Name

Keytruda

Active ingredients

Pembrolizumab (rch)

AusPAR Date

7 May 2018

Published

30 July 2018

Submission Number

PM-2015-04712-1-4 and PM -2016-02325-1-4

Submission Type

Major variation (both submissions were for new indications)

Decision

Approved