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NITYR nitisinone 10 mg tablet bottle, Orpharma Pty Ltd, CON-330
Product name
NITYR nitisinone 10 mg tablet bottle
Sponsor name
Orpharma Pty Ltd
Consent start
Consent no.
CON-330
Standard
Subsections 8(2), 9(3) and 11(5) and paragraphs 8(1)(j), (k), (o) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91).
Non-compliance with standard
The carton labels do not state all relevant warning statements (signal
headings), substances (excipients) with known effect (for lactose and sugars),
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 and the permitted
storage conditions are not stated.The bottle labels do not state all relevant
warning statements (signal headings), substances (excipients) with known effect
(for lactose and sugars), the name and quantity of the active ingredient are not
placed on the same line immediately underneath the trade name and the permitted
storage conditions are not stated.
Conditions imposed
The labels to which this consent applies are those provided with your
letter of application and are overstickered with the Australian sponsor's
details and the numbers as indicated.
A 'Dear Healthcare Professional' letter identical to that provided to the
TGA on 16 April 2019 advising of the labelling differences and the Australian
approved handling and storage conditions, must be provided with each of the
affected batches.
A copy of the Australian approved Product Information document will
accompany each 'Dear Healthcare Professional' letter.
Therapeutic product type
Prescription medicines