NITYR nitisinone 5 mg tablet bottle, Orpharma Pty Ltd, CON-981
Product name
NITYR nitisinone 5 mg tablet bottle
Sponsor name
Orpharma Pty Ltd
Consent start
Consent no.
CON-981
Standard
Subsection 11(5), subsection 8(2) and paragraphs 8(1)(n) and 8(1)(j) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product labels do not include storage conditions in the required format, a
machine-readable code in the required format, space for a dispensing label, and
do not declare the presence of lactose and sugars.
Conditions imposed
1. The labels to which this consent applies are those provided with the letter
of application and are overstickered with the warning statements
'Prescription Only Medicine' and 'Keep Out of Reach of Children', the
Australian sponsor's details and the numbers as indicated.
2. A 'Dear Healthcare Professional' letter as provided to the Therapeutic
Goods Administration dated 18 August 2022 must be provided with each of the
affected batches.
3. A copy of the Australian approved Product Information document will
accompany each 'Dear Healthcare Professional' letter.
Therapeutic product type
Prescription medicines