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ALBUREX 5 AU Human Albumin 50 g/L (5% w/v) 250 mL solution for intravenous infusion vial, CSL Behring Australia Pty Ltd, CON-1341
Product name
ALBUREX 5 AU Human Albumin 50 g/L (5% w/v) 250 mL solution for intravenous infusion vial
Sponsor name
CSL Behring Australia Pty Ltd
Consent start
Consent no.
CON-1341
Duration
The consent is effective from 21 March 2025 until 1 October 2031.
Standard
Part 2 Subsection 10(9) Schedule 1 Item 12 of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021
Non-compliance with standard
The products can now be manufactured from plasma from blood donors that do not
meet the requirement of a 3-month period of ineligibility from the date the
person last engaged in the sexual activity of a nature that puts the person at
an increased risk of acquiring infectious diseases that could be transmitted
through blood, cells or tissues.
Import, Supply, &/or Export
supply
Therapeutic product type
Blood, tissues, and biologicals