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LYTGOBI futibatinib 4 mg tablet blister pack, Taiho Pharma Oceania Pty Ltd, CON-1372
Product name
LYTGOBI futibatinib 4 mg tablet blister pack
Sponsor name
Taiho Pharma Oceania Pty Ltd
Consent start
Consent no.
CON-1372
Duration
The consent is effective from 23 June 2025 until 31 July 2027.
Standard
Paragraph 7(2)(b), 14(a)(v) and 14(a)(ix) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not conform because they have the Japanese labelled blister
strip, which uses Japanese text and does not contain the name of the active
ingredients in English, nor the sponsors name or trademark.
Conditions imposed
1. A ‘Dear Healthcare Provider’ letter will be supplied with each affected batch
describing the differences.
2. The blister strips will be packed into a carton with the Australian approved
packaging.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines