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: Digoxin-specific antibody fragment F(Ab) (Ovine)

Australian Public Assessment Report

AusPAR

AusPAR: Digoxin-specific antibody fragment f(Ab) (ovine) [PDF, 512.16 KB]

AusPAR: Digoxin-specific antibody fragment f(Ab) (ovine) [Word, 602.32 KB]

Attachment: Product Information: Digoxin-specific antibody fragment f(Ab) (ovine) [PDF, 243.74 KB]

Attachment: Product Information: Digoxin-specific antibody fragment f(Ab) (ovine) [Word, 223.86 KB]

Attachment: Extract from Clinical Evaluation Report: Digoxin-specific antibody fragment F(ab) ovine [PDF, 833.69 KB]

Attachment: Extract from Clinical Evaluation Report: Digoxin-specific antibody fragment F(ab) ovine [Word, 1.44 MB]

Device/Product Name

DigiFab

Active ingredients

Digoxin-specific antibody fragment F(Ab) (Ovine)

AusPAR Date

5 May 2014

Published

8 July 2014

Submission Number

PM-2012-03387-1-3

Submission Type

New biological entity

Decision

Approved