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CEPROTIN protein c 1000IU powder for injection vial with diluent vial, Takeda Pharmaceuticals Australia Pty Ltd, CON-1276
Product name
CEPROTIN protein c 1000IU 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.
Import, Supply, &/or Export
import, supply, and export
Therapeutic product type
Blood, tissues, and biologicals