AusPAR: Fentanyl citrate

Australian Public Assessment Report

AusPAR

AusPAR: Fentanyl citrate [PDF, 442.18 KB]

AusPAR: Fentanyl citrate [Word, 719.34 KB]

Attachment: Product Information: Fentanyl citrate [PDF, 182.13 KB]

Attachment: Product Information: Fentanyl citrate [Word, 121.16 KB]

Attachment: Extract from Clinical Evaluation Report: Fentanyl citrate [PDF, 1.09 MB]

Attachment: Extract from Clinical Evaluation Report: Fentanyl citrate [Word, 2.02 MB]

Device/Product Name

Abstral

Active ingredients

Fentanyl citrate

AusPAR Date

30 October 2013

Published

6 December 2013

Submission Number

PM-2011-03151-3-1

Submission Type

Major variation (new dosage form)

Decision

Approved