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AusPAR: Pembrolizumab (rch)

Australian Public Assessment Report

AusPAR

AusPAR Pembrolizumab (rch) [PDF, 3.56 MB]

AusPAR Pembrolizumab (rch) [DOCX, 6.42 MB]

Attachment: Product Information: Pembrolizumab (rch) [PDF, 230.46 KB]

Attachment: Product Information: Pembrolizumab (rch) [DOCX, 62.59 KB]

Attachment: Extract from Clinical Evaluation Report: Pembrolizumab (rch) [PDF, 2.91 MB]

Attachment: Extract from Clinical Evaluation Report: Pembrolizumab (rch) [DOCX, 5.49 MB]

Device/Product Name

Keytruda

Active ingredients

Pembrolizumab (rch)

AusPAR Date

14 October 2016

Published

18 October 2016

Submission Number

PM-2014-01928-1-4

Submission Type

New biological chemical entity

Decision

Approved

Product types

Prescription medicines