We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Cellular Therapies - T Cells - Brexucabtagene autoleucel, cryopreserved - T - Tecartus - Gilead Sciences Pty Ltd - Injection, intravenous infusion - Bag, Gilead Sciences Pty Ltd, CON-1095
Product name
Cellular Therapies - T Cells - Brexucabtagene autoleucel, cryopreserved - T - Tecartus - Gilead Sciences Pty Ltd - Injection, intravenous infusion - Bag
Sponsor name
Gilead Sciences Pty Ltd
Consent start
Consent no.
CON-1095
Duration
The consent is effective from 13 April 2023 until 30 June 2023.
Standard
Schedule 2, Part 1, Item 6 of Therapeutic Goods (Standard for Biologicals - Labelling Requirements) (TGO 107) Order 2021
Non-compliance with standard
The products do not conform with Schedule 2, Part 1, Item 6 of TGO 107 that
specifies that the name of the sponsor of the biological must be on the product
label attached to the container.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Blood, tissues, and biologicals