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AusPAR: Adalimumab

Australian Public Assessment Report

AusPAR

AusPAR: Adalimumab [PDF, 992.51 KB]

AusPAR: Adalimumab [Word, 1.13 MB]

Attachment: Product Information: Adalimumab [PDF, 954.21 KB]

Attachment: Product Information: Adalimumab [Word, 689.85 KB]

Attachment: Extract from Clinical Evaluation Report: Adalimumab [PDF, 2.83 MB]

Attachment: Extract from Clinical Evaluation Report: Adalimumab [Word, 5.76 MB]

Device/Product Name

Amgevita

Active ingredients

Adalimumab

AusPAR Date

25 June 2018

Published

16 July 2018

Submission Number

PM-2016-00845-1-1

Submission Type

Biosimilar medicine

Decision

Approved