FEIBA-NF factor eight inhibitor bypassing fraction 1000U powder for injection vial with diluent vial, Takeda Pharmaceuticals Australia Pty Ltd, CON-1276
Product name
FEIBA-NF factor eight inhibitor bypassing fraction 1000U powder for injection vial with diluent vial
Sponsor name
Takeda Pharmaceuticals Australia Pty Ltd
Consent start
Consent no.
CON-1276
Duration
The consent is effective from 4 October 2024 until 1 October 2031.
Standard
Part 2 Section 10 (9)
Schedule 1 Item 8 (b)(c). of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021
Schedule 1 Item 8 (b)(c). 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 of indefinite deferral for
variant Creutzfeldt-Jakob disease (vCJD) risk due to environmental/geographical
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. The product also does not
comply with the requirement of indefinite deferral for vCJD risk due to
iatrogenic exposure, including receiving a transfusion or injection of blood or
blood components while in England, Scotland, Wales, Northern Ireland or the Isle
of Man at any time on or after 1 January1980.
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
Blood, tissues, and biologicals