CSL New Zealand Privigen NZ normal immunoglobulin (human) 100 g/L, 10% solution for intravenous infusion, CSL Behring, CON-1212
Product name
CSL New Zealand Privigen NZ normal immunoglobulin (human) 100 g/L, 10% solution for intravenous infusion
Sponsor name
CSL Behring
Consent start
Consent no.
CON-1212
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
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