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Cellular Therapies - T Cells - Brexucabtagene autoleucel, cryopreserved - T - Tecartus - Injection, intravenous infusion - Bag, Gilead Sciences Pty Ltd, CON-1037
Product name
Cellular Therapies - T Cells - Brexucabtagene autoleucel, cryopreserved - T - Tecartus - Injection, intravenous infusion - Bag
Sponsor name
Gilead Sciences Pty Ltd
Consent start
Consent no.
CON-1037
Duration
The consent is effective from 23 November 2022 until 30 April 2023.
Standard
TGO 107: Schedule 2, Part 1, Item 6 of Therapeutic Goods (Standard for Biologicals - Labelling Requirements) (TGO 107) Order 2021
Non-compliance with standard
The product does not conform to the requirements of Schedule 2, Part 1, Item 6
of TGO 107 in that the name of the sponsor of the biological is not on the
product label attached to the container.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Blood, tissues, and biologicals