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AusPAR: Certolizumab pegol (rbe)

Australian Public Assessment Report

AusPAR

AusPAR: Certolizumab pegol (rbe) [PDF, 696.73 KB]

AusPAR: Certolizumab pegol (rbe) [Word, 1.11 MB]

Attachment: Product Information: Certolizumab pegol (rbe) [PDF, 408.72 KB]

Attachment: Product Information: Certolizumab pegol (rbe) [Word, 190.27 KB]

Attachment: Extract from Clinical Evaluation Report: Certolizumab pegol (rbe) [PDF, 1.36 MB]

Attachment: Extract from Clinical Evaluation Report: Certolizumab pegol (rbe) [Word, 3.13 MB]

Device/Product Name

Cimzia

Active ingredients

Certolizumab pegol (rbe)

AusPAR Date

2 November 2015

Published

25 November 2015

Submission Number

PM-2013-04590-1-3

Submission Type

Major variation (extension of indications)

Decision

Approved