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AusPAR: Mifepristone / misoprostol

Australian Public Assessment Report

AusPAR

AusPAR: Mifepristone/misoprostol [PDF, 545.53 KB]

AusPAR: Mifepristone/misoprostol [DOCX, 915.44 KB]

Attachment: Product Information: Mifepristone/misoprostol [PDF, 199.36 KB]

Attachment: Product Information: Mifepristone/misoprostol [DOCX, 71.42 KB]

Attachment: Extract from the Clinical Evaluation Report: Mifepristone/misoprostol [PDF, 449.05 KB]

Attachment: Extract from the Clinical Evaluation Report: Mifepristone/misoprostol [DOCX, 681.64 KB]

Device/Product Name

MS-2 Step

Active ingredients

Mifepristone / misoprostol

AusPAR Date

13 October 2014

Published

19 November 2014

Submission Number

PM-2013-01037-1-5

Submission Type

New combination of active ingredients

Decision

Approved

Product types

Prescription medicines