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LAZCLUZE lazertinib 80 mg film-coated tablets bottle, Janssen-Cilag Pty Ltd , CON-1366
Product name
LAZCLUZE lazertinib 80 mg film-coated tablets bottle
Sponsor name
Janssen-Cilag Pty Ltd
Consent start
Consent no.
CON-1366
Duration
The consent is effective from 16 June 2025 until 31 December 2025.
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 product does not conform with requirements as the product will be supplied
in 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 Poison Standard signal
headings and the Australian Registration number (AUST R number).
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines