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AusPAR: Asfotase alfa (rch)

Australian Public Assessment Report

AusPAR

AusPAR: Asfotase alfa (rch) [PDF, 1.44 MB]

AusPAR: Asfotase alfa (rch) [Word, 1.65 MB]

Attachment: Product Information: Asfotase alfa (rch) [PDF, 252.09 KB]

Attachment: Product Information: Asfotase alfa (rch) [Word, 151.38 KB]

Attachment: Extract from Clinical Evaluation Report: Asfotase alfa (rch) [PDF, 3.39 MB]

Attachment: Extract from Clinical Evaluation Report: Asfotase alfa (rch) [Word, 4.96 MB]

Device/Product Name

Strensiq

Active ingredients

Asfotase alfa (rch)

AusPAR Date

1 July 2016

Published

5 July 2016

Submission Number

PM-2014-03845-1-3

Submission Type

New chemical entity

Decision

Approved