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AusPAR: Ulipristal acetate

Australian Public Assessment Report

AusPAR

AusPAR Ulipristal acetate [PDF, 613.95 KB]

AusPAR Ulipristal acetate [DOCX, 603.11 KB]

Attachment: Product Information: Ulipristal acetate [PDF, 199.75 KB]

Attachment: Product Information: Ulipristal acetate [DOCX, 112.27 KB]

Attachment: Extract from Clinical Evaluation Report: Ulipristal acetate [PDF, 1.1 MB]

Attachment: Extract from Clinical Evaluation Report: Ulipristal acetate [DOCX, 2.02 MB]

Device/Product Name

Esmya

Active ingredients

Ulipristal acetate

AusPAR Date

19 October 2016

Published

2 November 2016

Submission Number

PM-2015-00776-1-5

Submission Type

Extension of indications

Decision

Approved

Product types

Prescription medicines