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AusPAR: Ofatumumab

Australian Public Assessment Report

AusPAR

AusPAR: Ofatumumab [PDF, 837.66 KB]

AusPAR: Ofatumumab [Word, 3.37 MB]

Attachment: Product Information for Ofatumumab [PDF, 285.3 KB]

Attachment: Product Information for Ofatumumab [Word, 123.13 KB]

Device/Product Name

Kesimpta

Active ingredients

Ofatumumab

AusPAR Date

24 June 2021

Published

19 August 2021

Submission Number

PM-2020-00666-1-1

Submission Type

Extension of indications and major variation (new dosage form)

Decision

Approved