AusPAR: Tofacitinib (as citrate)

Australian Public Assessment Report

AusPAR

AusPAR: Tofacitinib (as citrate) [PDF, 1.18 MB]

AusPAR: Tofacitinib (as citrate) [Word, 1.33 MB]

Attachment: Product Information: Tofacitinib (as citrate) [PDF, 565.19 KB]

Attachment: Product Information: Tofacitinib (as citrate) [Word, 560.16 KB]

Device/Product Name

Xeljanz

Active ingredients

Tofacitinib (as citrate)

AusPAR Date

10 September 2019

Published

25 September 2019

Submission Number

PM-2017-04764-1-1

Submission Type

Extension of indication and major variation (new strength)

Decision

Approved