AusPAR: Sevelamer carbonate

Australian Public Assessment Report

AusPAR

AusPAR: Sevelamer carbonate [PDF, 976.7 KB]

AusPAR: Sevelamer carbonate [Word, 1.33 MB]

Attachment: Product Information: Sevelamer carbonate (Renvela) [PDF, 227.2 KB]

Attachment: Product Information: Sevelamer carbonate (Renvela) [Word, 131.45 KB]

Attachment: Product Information: Sevelamer carbonate (Sevelamer carbonate sanofi) [PDF, 282.79 KB]

Attachment: Product Information: Sevelamer carbonate (Sevelamer carbonate sanofi) [Word, 130.18 KB]

Attachment: Product Information: Sevelamer carbonate (Sevelamer carbonate winthrop) [PDF, 279.14 KB]

Attachment: Product Information: Sevelamer carbonate (Sevelamer carbonate winthrop) [Word, 130.19 KB]

Attachment: Extract from Clinical Evaluation Report: Sevelamer carbonate [PDF, 3.83 MB]

Attachment: Extract from Clinical Evaluation Report: Sevelamer carbonate [Word, 7.77 MB]

Device/Product Name

Renvela / Sevelamer Carbonate Winthrop / Sevelamer Carbonate Sanofi

Active ingredients

Sevelamer carbonate

AusPAR Date

2 October 2015

Published

27 October 2015

Submission Number

PM-2013-04961-1-3

Submission Type

New chemical entity

Decision

Approved