Alburex 5 NZ human albumin 50 g/L (5% w/v) solution for intravenous infusion vial, CSL Behring, CON-1220
Product name
Alburex 5 NZ human albumin 50 g/L (5% w/v) solution for intravenous infusion vial
Sponsor name
CSL Behring
ARTG
Consent start
Consent no.
CON-1220
Standard
Part 2 Section 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 products do not meet the requirement for deferral of a person/plasma donor
who is at risk of prion disease because the person has been, or has potentially
been, exposed to the putative causative agent of one of the family of pathogenic
transmissible spongiform encephalopathies due to environmental exposure,
including living in or visiting 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
1. That CSL Behring informs the TGA of any new evidence that substantively
alters the estimated risks in the submitted information, such that they may
become unacceptable.
Therapeutic product type
Blood, tissues, and biologicals