AusPAR: Buprenorphine

Australian Public Assessment Report

AusPAR

AusPAR: Buprenorphine [PDF, 1.37 MB]

AusPAR: Buprenorphine [Word, 1.39 MB]

Attachment: Extract from Clinical Evaluation Report: Buprenorphine [PDF, 4.97 MB]

Attachment: Extract from Clinical Evaluation Report: Buprenorphine [Word, 7.24 MB]

Device/Product Name

Transtec

Active ingredients

Buprenorphine

AusPAR Date

13 December 2016

Published

16 December 2016

Last updated

3 January 2023

Submission Number

PM-2014-03891-1-1

Submission Type

Major variation (new indication, dose form and dose regimen)

Decision

Rejected