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AusPAR: Gadobutrol

Australian Public Assessment Report

AusPAR

AusPAR Gadobutrol [PDF, 1.14 MB]

AusPAR Gadobutrol [DOCX, 1.2 MB]

Attachment: Product Information: Gadobutrol [PDF, 257.43 KB]

Attachment: Product Information: Gadobutrol [DOCX, 131.57 KB]

Attachment: Extract from Clinical Evaluation Report: Gadobutrol [PDF, 1.09 MB]

Attachment: Extract from Clinical Evaluation Report: Gadobutrol [DOCX, 2.49 MB]

Device/Product Name

Gadovist 1.0

Active ingredients

Gadobutrol

AusPAR Date

31 January 2017

Published

9 February 2017

Submission Number

PM-2015-01572-1-2

Submission Type

Major variation

Decision

Approved

Product types

Prescription medicines