AusPAR: Follitropin alfa (rch)

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Australian Public Assessment Report

12 April 2016
AusPAR Details
AusPAR
AusPAR: Follitropin alfa (rch) (pdf, 810 KB)
AusPAR: Follitropin alfa (rch) (docx, 1 MB)
Attachment: Product Information: Follitropin alfa (rch) (Bemfola) (pdf, 267 KB)
Attachment: Product Information: Follitropin alfa (rch) (Bemfola) (docx, 56 KB)
Attachment: Product Information: Follitropin alfa (rch) (Afolia) (pdf, 266 KB)
Attachment: Product Information: Follitropon alfa (rch) (Afolia) (docx, 57 KB)
Attachment: Extract from Clinical Evaluation Report: Follitropin alfa (rch) (pdf, 928 KB)
Attachment: Extract from Clinical Evaluation Report: Follitropin alfa (rch) (docx, 1 MB)
Active Ingredient
Follitropin alfa (rch)
Product Name
Bemfola / Afolia
Sponsor
Finox Biotech Australia Pty Ltd
Submission Number
PM-2014-03163-1-5
Submission Type
Biosimilar medicine, Extension of indications
Decision
Approved
AusPAR Date
8 April 2016
Publication Date

12 April 2016
Category: 
Prescription medicines
Tags: 
AusPARs
URL: 
https://www.tga.gov.au/node/725424