AusPAR: Elosulfase alfa (rch)

Australian Public Assessment Report

AusPAR

AusPAR: Elosulfase alfa (rch) [PDF, 1.27 MB]

AusPAR: Elosulfase alfa (rch) [Word, 2.02 MB]

Attachment: Product information: Elosulfase alfa (rch) [PDF, 466.75 KB]

Attachment: Product information: Elosulfase alfa (rch) [Word, 271.28 KB]

Attachment: Extract from the Clinical Evaluation Report: Elosulfase alfa (rch) [PDF, 3.86 MB]

Attachment: Extract from the Clinical Evaluation Report: Elosulfase alfa (rch) [Word, 5.77 MB]

Device/Product Name

Vimizim

Active ingredients

Elosulfase alfa (rch)

AusPAR Date

8 April 2015

Published

1 June 2015

Submission Number

PM-2013-02807-1-3

Submission Type

New chemical entity

Decision

Approved