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AusPAR: Onasemnogene abeparvovec

Australian Public Assessment Report

AusPAR

AusPAR: Onasemnogene abeparvovec [PDF, 1.28 MB]

AusPAR: Onasemnogene abeparvovec [Word, 2.96 MB]

Attachment 1: Product Information for Onasemnogene abeparvovec [PDF, 454.27 KB]

Attachment 1: Product Information for Onasemnogene abeparvovec [Word, 249.03 KB]

Device/Product Name

Zolgensma

Active ingredients

Onasemnogene abeparvovec

AusPAR Date

6 April 2021

Published

22 April 2021

Submission Number

PM-2019-05979-1-3

Submission Type

New biological entity

Decision

Approved