CSL Rh(D) IMMUNOGLOBULIN VF (human) 250 IU injection vial, CSL Behring Australia Pty Ltd, CON-1223
Product name
CSL Rh(D) IMMUNOGLOBULIN VF (human) 250 IU injection vial
Sponsor name
CSL Behring Australia Pty Ltd
Consent start
Consent no.
CON-1223
Standard
Part 2 Section 10 (4) Schedule 1 Item 10 (d). 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 TGO 108 in that where
single-use equipment is used, and it is less than 4 months since the body
piercing procedure, CSLB supply the affected the plasma derived medicinal
product.
Conditions imposed
That the sponsor continues to monitor the literature and informs the Therapeutic
Goods Administration of any new evidence that substantively alters the
estimated risks, such that they become unacceptable.
Therapeutic product type
Blood, tissues, and biologicals