CSL Taiwan AlbuRx 20 TW human albumin 200g/L (20% w/v) solution for intravenous infusion vial, CSL Behring (Australia) Pty Ltd, CON-1422
Product name
CSL Taiwan AlbuRx 20 TW human albumin 200g/L (20% w/v) solution for intravenous infusion vial
Sponsor name
CSL Behring (Australia) Pty Ltd
Consent start
Consent no.
CON-1422
Duration
The consent is effective from 23 October 2025 until 1 October 2031.
Standard
Subsection 10(9) Schedule 1 Items 8(b) and (c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021
Non-compliance with standard
The products do not conform because they can now be manufactured from plasma
sourced from Taiwan 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; or
received a transfusion of blood or blood components while in England, Scotland,
Wales, Northern Ireland or the Isle of Man at any time on or after 1 January
1980.
Conditions imposed
The sponsors are required to inform the TGA of any new evidence that
substantively alters the estimated risks in the submitted information, such that
they may become unacceptable.
Import, Supply, &/or Export
export
Therapeutic product type
Blood, tissues, and biologicals