ORFADIN nitisinone 20 mg capsule bottle, A Menarini Australia Pty Ltd , CON-1303
Product name
ORFADIN nitisinone 20 mg capsule bottle
Sponsor name
A Menarini Australia Pty Ltd
Consent start
Consent no.
CON-1303
Duration
The consent is effective from 16 December 2024 until 30 September 2026.
Standard
The product(s) do not conform to the requirements of Subsection 9(3) and paragraphs 7(2)(b), 7(2)(d), 8(1)(o) and 8(2)(a) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines. 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 and space for a dispensing label 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
1. The labels to which this consent applies are those provided with your letter
of application dated 28 November 2024.
2. The labels will be supplied with the Australian-specific stickers described
in the application dated 28 November 2024 (Two stickers, one with English
information and the other a machine-readable code).
Therapeutic product type
Prescription medicines