AusPAR: Taliglucerase alfa rpc

Australian Public Assessment Report

AusPAR

AusPAR: Taliglucerase alfa rpc [PDF, 1.92 MB]

AusPAR: Taliglucerase alfa rpc [Word, 894.8 KB]

Attachment: Product information: Taliglucerase alfa rpc [PDF, 162.96 KB]

Attachment: Product information: Taliglucerase alfa rpc [Word, 74.66 KB]

Attachment: Extract from the Clinical Evaluation Report [1]: Taliglucerase alfa rpc [PDF, 2.14 MB]

Attachment: Extract from the Clinical Evaluation Report [1]: Taliglucerase alfa rpc [Word, 3.59 MB]

Attachment: Extract from the Clinical Evaluation Report [2]: Taliglucerase alfa rpc [PDF, 1.74 MB]

Attachment: Extract from the Clinical Evaluation Report [2]: Taliglucerase alfa rpc [Word, 2.62 MB]

Device/Product Name

Elelyso

Active ingredients

Taliglucerase alfa rpc

AusPAR Date

14 October 2014

Published

3 November 2014

Submission Number

PM-2013-00303-1-3

Submission Type

New biological entity

Decision

Approved