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AusPAR: Misoprostol

Australian Public Assessment Report

AusPAR

AusPAR: Misoprostol [PDF, 1.1 MB]

AusPAR: Misoprostol [Word, 2.69 MB]

Attachment: Product Information: Misoprostol [PDF, 137.09 KB]

Attachment: Product Information: Misoprostol [Word, 102.6 KB]

Attachment: Extract from Clinical Evaluation Report: Misoprostol [PDF, 637.83 KB]

Attachment: Extract from Clinical Evaluation Report: Misoprostol [Word, 801.78 KB]

Device/Product Name

Misodel/ Misopess

Active ingredients

Misoprostol

AusPAR Date

23 April 2014

Published

2 June 2014

Submission Number

PM-2012-03740-1-5

Submission Type

Major variation (extension of indication, new dose form, new route of administration)

Decision

Approved