AusPAR: Glycopyrronium bromide / Indacaterol maleate

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20 November 2014
AusPAR Details
AusPAR
AusPAR: Indacaterol maleate / Glycopyrronium bromide (pdf, 1 MB)
AusPAR: Indacaterol maleate / Glycopyrronium bromide (docx, 1 MB)
Attachment: Product information: Indacaterol maleate / Glycopyrronium bromide (pdf, 354 KB)
Attachment: Product information: Indacaterol maleate / Glycopyrronium bromide (docx, 378 KB)
Attachment: Extract from the Clinical Evaluation Report: Indacaterol maleate / Glycopyrronium bromide (pdf, 1 MB)
Attachment: Extract from the Clinical Evaluation Report: Indacaterol maleate / Glycopyrronium bromide (docx, 2 MB)
Active Ingredient
Glycopyrronium bromide / Indacaterol maleate
Product Name
Ultibro Breezhaler 110/50
Sponsor
Novartis Pharmaceuticals Australia Pty Ltd
Submission Number
PM-2012-04395-1-5
Submission Type
New combination of active ingredients
Decision
Approved
AusPAR Date
23 October 2014
Publication Date

20 November 2014
Category: 
Prescription medicines
Tags: 
AusPARs
URL: 
https://www.tga.gov.au/node/283540