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CSL Rh(D) IMMUNOGLOBULIN VF (human) 250 IU injection vial, CSL Behring Australia Pty Ltd, CON-1340
Product name
CSL Rh(D) IMMUNOGLOBULIN VF (human) 250 IU injection vial
Sponsor name
CSL Behring Australia Pty Ltd
Consent start
Consent no.
CON-1340
Duration
The consent is effective from 21 March 2025 until 1 October 2031.
Standard
Part 2, subsection 10(9) and Schedule 1, Item 14 of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021
Non-compliance with standard
The product does not comply with the requirement for at least a 2-week deferral
from the date of full recovery for a person who has a symptomatic infection,
fever or infectious illness for recurrent or subsequent Herpes Simplex Virus
(HSV) infection.
Import, Supply, &/or Export
supply
Therapeutic product type
Blood, tissues, and biologicals