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AusPAR: Ulipristal acetate

Australian Public Assessment Report

AusPAR

AusPAR: Ulipristal acetate [PDF, 1.05 MB]

AusPAR: Ulipristal acetate [Word, 1.56 MB]

Attachment: Product Information: Ulipristal acetate [PDF, 268.87 KB]

Attachment: Product Information: Ulipristal acetate [Word, 107.08 KB]

Attachment: Extract from Clinical Evaluation Report: Ulipristal acetate [PDF, 507.32 KB]

Attachment: Extract from Clinical Evaluation Report: Ulipristal acetate [Word, 658.33 KB]

Device/Product Name

EllaOne

Active ingredients

Ulipristal acetate

AusPAR Date

4 September 2015

Published

15 September 2015

Submission Number

PM-2013-04154-1-5

Submission Type

New chemical entity

Decision

Approved