AusPAR: Tofacitinib (as citrate)

Australian Public Assessment Report

AusPAR

AusPAR: Tofacitinib (as citrate) [PDF, 2.54 MB]

AusPAR: Tofacitinib (as citrate) [DOCX, 2.72 MB]

Attachment: Product Information: Tofacitinib (as citrate) [PDF, 436 KB]

Attachment: Product Information: Tofacitinib (as citrate) [DOCX, 433.56 KB]

Attachment: Extract from the Clinical Evaluation Report (first and second round): Tofacitinib (as citrate) [PDF, 1018.26 KB]

Attachment: Extract from the Clinical Evaluation Report (first and second round): Tofacitinib (as citrate) [DOCX, 908.17 KB]

Attachment: Extract from the Clinical Evaluation Report (third round): Tofacitinib (as citrate) [PDF, 432.08 KB]

Attachment: Extract from the Clinical Evaluation Report (third round): Tofacitinib (as citrate) [DOCX, 369.56 KB]

Attachment: Extract from the Clinical Evaluation Report (fourth round): Tofacitinib (as citrate) [PDF, 471.57 KB]

Attachment: Extract from the Clinical Evaluation Report (fourth round): Tofacitinib (as citrate) [DOCX, 749.82 KB]

Device/Product Name

Xeljanz

Active ingredients

Tofacitinib (as citrate)

AusPAR Date

6 March 2015

Published

1 April 2015

Submission Number

PM-2012-00788-3-3

Submission Type

New chemical entity

Decision

Rejected (initial)Approved (final)

Product types

Prescription medicines