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HIZENTRA human normal immunoglobulin 20% solution for subcutaneous injection 5 mL vial, CSL Behring (Australia) Pty Ltd, CON-1378
Product name
HIZENTRA human normal immunoglobulin 20% solution for subcutaneous injection 5 mL vial
Sponsor name
CSL Behring (Australia) Pty Ltd
Consent start
Consent no.
CON-1378
Duration
The consent is effective from 4 July 2025 until 1 October 2031.
Standard
subsection 10(9) Schedule 1 Item 8(b) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021
Non-compliance with standard
The product can now be manufactured from plasma sourced from European plasma
donors who have lived in or visited England, Scotland, Wales, Northern Ireland
or the Isle of Man for a cumulative period of 6 months or more at any time
between 1 January 1980 and 31 December 1996.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Blood, tissues, and biologicals