AusPAR: Tolvaptan

Australian Public Assessment Report

AusPAR

AusPAR: Tolvaptan [PDF, 748.35 KB]

AusPAR: Tolvaptan [Word, 1.11 MB]

Attachment: Product Information: Tolvaptan [PDF, 338.6 KB]

Attachment: Product Information: Tolvaptan [Word, 260.05 KB]

Attachment: Extract from Clinical Evaluation Tolvaptan [Word, 6.29 MB]

Attachment: Extract from Clinical Evaluation Tolvaptan [PDF, 2.94 MB]

Device/Product Name

Jinarc

Active ingredients

Tolvaptan

AusPAR Date

9 February 2018

Published

22 February 2018

Submission Number

PM-2015-04368-1-3

Submission Type

Extension of indications, New dosage

Decision

Approved