Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.

AusPAR: Ezetimibe / Rosuvastatin (as calcium)

Australian Public Assessment Report

AusPAR

AusPAR: Ezetimibe / Rosuvastatin (as calcium) [PDF, 635.82 KB]

AusPAR: Ezetimibe / Rosuvastatin (as calcium) [Word, 537.42 KB]

Attachment: Product Information: Ezetimibe / Rosuvastatin (as calcium) [PDF, 336.67 KB]

Attachment: Product Information: Ezetimibe / Rosuvastatin (as calcium) [Word, 120.53 KB]

Attachment: Extract from the Clinical Evaluation Report: Ezetimibe / Rosuvastatin (as calcium) [PDF, 1 MB]

Attachment: Extract from the Clinical Evaluation Report: Ezetimibe / Rosuvastatin (as calcium) [Word, 1.01 MB]

Device/Product Name

Rosuzet, Ezalo

Active ingredients

Ezetimibe / Rosuvastatin (as calcium)

AusPAR Date

29 January 2015

Published

5 March 2015

Submission Number

PM-2013-02434-1-3

Submission Type

New fixed dose combination

Decision

Approved