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LAZCLUZE lazertinib 80 mg film-coated tablets bottle, Janssen-Cilag Pty Ltd, CON-1434
Product name
LAZCLUZE lazertinib 80 mg film-coated tablets bottle
Sponsor name
Janssen-Cilag Pty Ltd
Consent start
Consent no.
CON-1434
Duration
The consent is effective from 2 December 2025 until 31 December 2027.
Standard
Paragraph 8(1)(i); Subsection 8(2); Subsection 9(3) and Subsection 11(5) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not conform because the products will be supplied with the
American labelled packaging, which contains the following differences: -Sponsor
details are not for the Australian Sponsor (Janssen Biotech, Inc rather than
Janssen-Cilag Pty Ltd); -There is no dedicated space for the dispensing label
that is 30mm x 70 mm as required; -The name of the active ingredient and the
quantity of the active ingredient are broken up by the word ‘tablet’; -The
storage conditions are included as "Store at 20°C to 25°C (68°F to 77°F);
excursions permitted between 15°C to 30°C (59°F to 86°F) [see US Controlled Room
Temperature]" whilst the Australian approved storage details are “Store below
30°C”.
Conditions imposed
1. A ‘Dear Healthcare Provider’ letter will be supplied with each affected batch
describing the label differences and how to contact the sponsor.
2. The labels will be over-stickered to include the Poisons Standard signal
headings and the Australian Registration number (AUST R number).
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines