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
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.
Therapeutic product type
Prescription medicines