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ORFADIN nitisinone 4 mg/mL oral suspension bottle, A Menarini Australia Pty Ltd , CON-1418
Product name
ORFADIN nitisinone 4 mg/mL oral suspension bottle
Sponsor name
A Menarini Australia Pty Ltd
Consent start
Consent no.
CON-1418
Duration
The consent is effective from 9 October 2025 until 30 September 2026.
Standard
subsection 9(3) and paragraphs 7(2)(b), 7(2)(d), 8(1)(o) and 8(2)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not comply because the carton label (except for the text
contained on the over-sticker) are not in English, the text size (except for the
text on the over sticker) does not meet the requirements, the trade name is not
repeated on 3 non-opposing sides and space for a dispensing label is not
included.
Conditions imposed
The labels will be supplied with two Australian-specific stickers: one sticker
with English information and the other sticker with a machine-readable code.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines