AusPAR: Ibrutinib

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Australian Public Assessment Report

5 April 2016
AusPAR Details
AusPAR
AusPAR: Ibrutinib (pdf, 1 MB)
AusPAR: Ibrutinib (docx, 2 MB)
Attachment: Product Information: Ibrutinib (pdf, 431 KB)
Attachment: Product Information: Ibrutinib (doc, 701 KB)
Attachment: Extract from Clinical Evaluation Report: Ibrutinib (pdf, 3 MB)
Attachment: Extract from Clinical Evaluation Report: Ibrutinib (docx, 12 MB)
Active Ingredient
Ibrutinib
Product Name
Imbruvica
Sponsor
Janssen-Cilag Pty Ltd
Submission Number
PM-2014-02780-1-4
Submission Type
New chemical entity
Decision
Approved
AusPAR Date
2 February 2016
Publication Date

5 April 2016
Category: 
Prescription medicines
Tags: 
AusPARs
URL: 
https://www.tga.gov.au/node/724679