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AusPAR: Bosentan

Australian Public Assessment Report

AusPAR

AusPAR: Bosentan [PDF, 1.14 MB]

AusPAR: Bosentan [Word, 2.89 MB]

Attachment: Extract from Clinical Evaluation Bosentan [PDF, 3.67 MB]

Attachment: Extract from Clinical Evaluation Bosentan [Word, 10.21 MB]

Device/Product Name

Tracleer

Active ingredients

Bosentan

AusPAR Date

25 June 2018

Published

19 July 2018

Submission Number

PM-2015-04745-1-3

Submission Type

Major variation: new dosage form and new strength

Decision

Rejected