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: Ferric derisomaltose

Australian Public Assessment Report

AusPAR

AusPAR: Ferric derisomaltose [PDF, 1.49 MB]

AusPAR: Ferric derisomaltose [Word, 1.72 MB]

Attachment: Product Information: Ferric derisomaltose [PDF, 194.69 KB]

Attachment: Product Information: Ferric derisomaltose [Word, 60.68 KB]

Attachment: Extract from Clinical Evaluation: Ferric derisomaltose [PDF, 2.95 MB]

Attachment: Extract from Clinical Evaluation: Ferric derisomaltose [Word, 3.68 MB]

Device/Product Name

Monofer

Active ingredients

Ferric derisomaltose

AusPAR Date

5 November 2018

Published

24 January 2019

Submission Number

PM-2016-02728-1-4

Submission Type

New chemical entity

Decision

approved