AusPAR: Follitropin alfa (rch)

Australian Public Assessment Report

AusPAR

AusPAR: Follitropin alfa (rch) [PDF, 809.73 KB]

AusPAR: Follitropin alfa (rch) [DOCX, 1.09 MB]

Attachment: Product Information: Follitropin alfa (rch) (Bemfola) [PDF, 266.99 KB]

Attachment: Product Information: Follitropin alfa (rch) (Bemfola) [DOCX, 56.05 KB]

Attachment: Product Information: Follitropin alfa (rch) (Afolia) [PDF, 265.77 KB]

Attachment: Product Information: Follitropon alfa (rch) (Afolia) [DOCX, 57.43 KB]

Attachment: Extract from Clinical Evaluation Report: Follitropin alfa (rch) [PDF, 927.94 KB]

Attachment: Extract from Clinical Evaluation Report: Follitropin alfa (rch) [DOCX, 1.33 MB]

Device/Product Name

Bemfola / Afolia

Active ingredients

Follitropin alfa (rch)

AusPAR Date

8 April 2016

Published

12 April 2016

Submission Number

PM-2014-03163-1-5

Submission Type

Biosimilar medicine, Extension of indications

Decision

Approved

Product types

Prescription medicines