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ORFADIN nitisinone 4 mg/mL oral suspension bottle, A Menarini Australia Pty Ltd, CON-758
Product name
ORFADIN nitisinone 4 mg/mL oral suspension bottle
Sponsor name
A Menarini Australia Pty Ltd
Consent start
Consent no.
CON-758
Duration
The consent is effective from 3 February 2021 until 1 October 2026.
Standard
Subsection 9(3) and paragraphs 7(2)(b), 7(2)(d), 8(1)(n), 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 carton labels for ORFADIN 2mg, 5mg, 10mg and 20mg capsules (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 carton label for ORFADIN 4mg/mL oral suspension (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, space for a dispensing label is not included and a machine readable code is not included.
The bottle labels for ORFADIN 2mg, 5mg, 10mg and 20mg capsules do not include the name and quantity of the active ingredient immediately underneath the trade name.
Conditions imposed
The labels to which this consent applies are those provided as part of the application.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines