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NITYR nitisinone 5 mg tablet bottle, Orpharma Pty Ltd, CON-330

Product name
NITYR nitisinone 5 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

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