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ORFADIN nitisinone 2 mg capsule bottle, A Menarini Australia Pty Ltd , CON-1417
Product name
ORFADIN nitisinone 2 mg capsule bottle
Sponsor name
A Menarini Australia Pty Ltd
ARTG details
Consent start
Consent no.
CON-1417
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 labels (except for the text
contained on the over-sticker) are not in English, the text size (except for the
text contained on the over-sticker) does not meet the requirements, the trade
name is not repeated on 3 non-opposing sides, space for a dispensing label is
not included, the name and quantity of the active ingredient are not placed on
the same line immediately underneath the trade name. • The bottle labels do not
include the name and quantity of the active ingredient immediately underneath
the trade name.
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