AusPAR: Nusinersen (as heptadecasodium)

Australian Public Assessment Report

AusPAR

AusPAR: Nusinersen (as heptadecasodium) [PDF, 839.36 KB]

AusPAR: Nusinersen (as heptadecasodium) [Word, 447.49 KB]

Attachment: Product Information: Nusinersen (as heptadecasodium) [PDF, 344.33 KB]

Attachment: Product Information: Nusinersen (as heptadecasodium) [Word, 590.88 KB]

Attachment: Extract from Clinical Evaluation Nusinersen (as heptadecasodium) [PDF, 2.63 MB]

Attachment: Extract from Clinical Evaluation Nusinersen (as heptadecasodium) [Word, 9.48 MB]

Device/Product Name

Spinraza

Active ingredients

Nusinersen (as heptadecasodium)

AusPAR Date

13 August 2018

Published

29 August 2018

Submission Number

PM-2016-04042-1-3

Submission Type

New chemical entity

Decision

Approved