AusPAR: Budesonide

Australian Public Assessment Report

AusPAR

AusPAR: Budesonide [PDF, 676.13 KB]

AusPAR: Budesonide [Word, 672.06 KB]

Attachment: Product Information: Budesonide [PDF, 218.17 KB]

Attachment: Product Information: Budesonide [Word, 70.12 KB]

Attachment: Extract from Clinical Evaluation Report: Budesonide [PDF, 1.48 MB]

Attachment: Extract from Clinical Evaluation Report: Budesonide [Word, 3.12 MB]

Device/Product Name

Cortiment

Active ingredients

Budesonide

AusPAR Date

11 January 2016

Published

16 February 2016

Submission Number

PM-2014-04155-1-1

Submission Type

Major variation (new dosage form and new indication)

Decision

Approved