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AusPAR: Naloxegol oxalate

Australian Public Assessment Report

AusPAR

AusPAR: Naloxegol oxalate [PDF, 1.83 MB]

AusPAR: Naloxegol oxalate [Word, 1.86 MB]

Attachment: Product Information: Naloxegol oxalate [PDF, 191 KB]

Attachment: Production Information [Word, 128 KB]

Attachment: Extract from Clinical Evaluation Report: Naloxegol oxalate [PDF, 3.03 MB]

Attachment: Extract from Clinical Evaluation Report: Naloxegol oxalate [Word, 4.52 MB]

Device/Product Name

Movantik

Active ingredients

Naloxegol oxalate

AusPAR Date

1 June 2016

Published

6 June 2016

Submission Number

PM-2014-03892-1-1

Submission Type

New chemical entity

Decision

Approved