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AusPAR: teduglutide

Australian Public Assessment Report

AusPAR

AusPAR: Teduglutide [PDF, 580.75 KB]

AusPAR: Teduglutide [DOCX, 420.74 KB]

Attachment: Product Information: Teduglutide [PDF, 307.61 KB]

Attachment: Product Information: Teduglutide [DOCX, 187.66 KB]

Attachment: Extract from Clinical Evaluation Report: Teduglutide [PDF, 1.72 MB]

Attachment: Extract from Clinical Evaluation Report: Teduglutide [DOCX, 2.71 MB]

Device/Product Name

Revestive

Active ingredients

Teduglutide

AusPAR Date

6 April 2018

Published

12 April 2018

Submission Number

PM-2016-01314-1-1

Submission Type

New biological entity

Decision

Approved

Product types

Prescription medicines