Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.

AusPAR: Sebelipase alfa

Australian Public Assessment Report

AusPAR

AusPAR: Sebelipase alfa [PDF, 973.6 KB]

AusPAR: Sebelipase alfa [Word, 1.36 MB]

Attachment: Product Information: Sebelipase alfa [PDF, 296.39 KB]

Attachment: Product Information: Sebelipase alfa [Word, 246.75 KB]

Attachment: Extract from Clinical Evaluation Sebelipase alfa [PDF, 3.62 MB]

Attachment: Extract from Clinical Evaluation Sebelipase alfa [Word, 6.16 MB]

Device/Product Name

Kanuma

Active ingredients

Sebelipase alfa

AusPAR Date

14 June 2018

Published

19 July 2018

Submission Number

PM-2016-01313-1-3

Submission Type

New biological entity

Decision

Approved