PRIVIGEN AU normal immunoglobulin (human) 20g (100g/L, 10%) solution for intravenous infusion, CSL Behring (Australia) Pty Ltd, CON-1440
Product name
PRIVIGEN AU normal immunoglobulin (human) 20g (100g/L, 10%) solution for intravenous infusion
Sponsor name
CSL Behring (Australia) Pty Ltd
ARTG details
AUST R 328603
Batches
P100908173
Consent start
Consent no.
CON-1440
Duration
The consent is effective from 9 December 2025 until 31 August 2028.
Standard
'Immunoglobulin A' Test in the 'Human Normal Immunoglobulin for Intravenous Administration' Monograph (07/2025:0918) of European Pharmacopoeia
Non-compliance with standard
The product does not comply with the test for 'Immunoglobulin A' in this
monograph as the content of immunoglobulin A is greater than the maximum content
stated on the label.
Conditions imposed
The product must comply with all other applicable parts of the European
Pharmacopoeia 07/2025:0918 'Human Normal Immunoglobulin for Intravenous
Administration' Monograph and other applicable standards.
Import, Supply, &/or Export
supply
Therapeutic product type
Prescription medicines