AusPAR: Gadobutrol

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Australian Public Assessment Report

13 July 2015
AusPAR Details
AusPAR
AusPAR: Gadobutrol (pdf, 618 KB)
AusPAR: Gadobutrol (docx, 1 MB)
Attachment: Product information: Gadobutrol (pdf, 271 KB)
Attachment: Product information: Gadobutrol (docx, 113 KB)
Attachment: Extract from the Clinical Evaluation Report: Gadobutrol (pdf, 5 MB)
Attachment: Extract from the Clinical Evaluation Report: Gadobutrol (docx, 6 MB)
Active Ingredient
Gadobutrol
Product Name
Gadovist
Sponsor
Bayer Australia Ltd
Submission Number
PM-2013-04968-1-2
Submission Type
Extension of indications
Decision
Approved
AusPAR Date
1 June 2015
Publication Date

13 July 2015
Category: 
Prescription medicines
Tags: 
AusPARs
URL: 
https://www.tga.gov.au/node/707229