HIZENTRA AU Human Normal Immunoglobulin 20% Solution for Subcutaneous Injection 50 mL vial, CSL Behring (Australia) Pty Ltd, CON-1164
Product name
HIZENTRA AU Human Normal Immunoglobulin 20% Solution for Subcutaneous Injection 50 mL vial
Sponsor name
CSL Behring (Australia) Pty Ltd
ARTG
Consent start
Consent no.
CON-1164
Standard
Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021
Non-compliance with standard
The products that do not conform to the requirements of Therapeutic Goods
(Standard for Human Cell and Tissue Products '“ Donor Screening Requirements)
(TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c),
in that the blood and plasma donors will not be deferred for potential
environmental exposure to vCJD for having spent a cumulative length of time of 6
months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK
at any time on or after 1 January 1980.
Conditions imposed
The sponsor continues to monitor the literature and informs the TGA of any new
evidence that substantively alters the estimated risks, such that they become
unacceptable.
Therapeutic product type
Prescription medicines