AusPAR: Gadobutrol

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Australian Public Assessment Report

9 February 2017
AusPAR Details
AusPAR
AusPAR Gadobutrol (pdf, 1 MB)
AusPAR Gadobutrol (docx, 1 MB)
Attachment: Product Information: Gadobutrol (pdf, 257 KB)
Attachment: Product Information: Gadobutrol (docx, 132 KB)
Attachment: Extract from Clinical Evaluation Report: Gadobutrol (pdf, 1 MB)
Attachment: Extract from Clinical Evaluation Report: Gadobutrol (docx, 2 MB)
Active Ingredient
Gadobutrol
Product Name
Gadovist 1.0
Sponsor
Bayer Australia Ltd
Submission Number
PM-2015-01572-1-2
Submission Type
Major variation
Decision
Approved
AusPAR Date
31 January 2017
Publication Date

9 February 2017
Category: 
Prescription medicines
Tags: 
AusPARs
URL: 
https://www.tga.gov.au/node/735138