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VITRAKVI larotrectinib (as sulfate) 20 mg/mL bottle, Bayer Australia Ltd, CON-1339
Product name
VITRAKVI larotrectinib (as sulfate) 20 mg/mL bottle
Sponsor name
Bayer Australia Ltd
Consent start
Consent no.
CON-1339
Duration
The consent is effective from 21 March 2025 until 30 September 2026.
Standard
Paragraph 8(1)(o) 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 carton does not have the name of the
medicine printed on the top or bottom panel, meaning it is not on three opposing
sides.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines