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CSL INDONESIA ALBAPURE 20 human albumin 20% (200g/L) injection vial, CSL Behring (Australia) Pty Ltd, CON-1364
Product name
CSL INDONESIA ALBAPURE 20 human albumin 20% (200g/L) injection vial
Sponsor name
CSL Behring (Australia) Pty Ltd
Consent start
Consent no.
CON-1364
Duration
The consent is effective from 13 June 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 does not comply as the product can now be manufactured from plasma
sourced from Hong Kong 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.
Conditions imposed
Import, Supply, &/or Export
export
Therapeutic product type
Blood, tissues, and biologicals