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AusPAR: Gadobutrol

Australian Public Assessment Report

AusPAR

AusPAR: Gadobutrol [PDF, 618.16 KB]

AusPAR: Gadobutrol [Word, 1.09 MB]

Attachment: Product information: Gadobutrol [PDF, 271.37 KB]

Attachment: Product information: Gadobutrol [Word, 112.88 KB]

Attachment: Extract from the Clinical Evaluation Report: Gadobutrol [PDF, 4.69 MB]

Attachment: Extract from the Clinical Evaluation Report: Gadobutrol [Word, 6.26 MB]

Device/Product Name

Gadovist

Active ingredients

Gadobutrol

AusPAR Date

1 June 2015

Published

13 July 2015

Submission Number

PM-2013-04968-1-2

Submission Type

Extension of indications

Decision

Approved