Cellular Therapies - T cells-Ciltacabtagene autoleucel, cryopreserved-T-CARVYKTI - Janssen-Cilag Pty Ltd - Injection, intravenous infusion - Bag, Janssen-Cilag Pty Ltd , CON-1462
Product name
Cellular Therapies - T cells-Ciltacabtagene autoleucel, cryopreserved-T-CARVYKTI - Janssen-Cilag Pty Ltd - Injection, intravenous infusion - Bag
Sponsor name
Janssen-Cilag Pty Ltd
Consent start
Consent no.
CON-1462
Duration
The consent is effective from 17 March 2026 until 4 November 2026.
Standard
Schedule 2, Part 2, Item 4(a) of Therapeutic Goods (Standard for Biologicals - Labelling Requirements) (TGO 107) Order 2021
Non-compliance with standard
Product labels (immediate bag label and cassette label) are printed with an old
Sponsor postal address.
Conditions imposed
The new address (17 Khartoum Road, Macquarie Park NSW 2113) is included on PI
and CMI documents. There is a mail-forwarding arrangement in place.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Blood, tissues, and biologicals