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NITYR nitisinone 10 mg tablet bottle, Orpharma Pty Ltd, CON-1284
Product name
NITYR nitisinone 10 mg tablet bottle
Sponsor name
Orpharma Pty Ltd
Consent start
Consent no.
CON-1284
Duration
The consent is effective from 25 October 2024 until 31 December 2026.
Standard
Subsection 11(5); subsection 8(2); paragraphs 8(1)(n) and 8(1)(j) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The 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
The labels to which this consent applies are over-stickered with the warning statements “Prescription Only Medicine” and “Keep Out of Reach of Children”, the Australian sponsor’s details and the AUST R numbers. A ‘Dear Healthcare Professional’ letter 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. A copy of the Australian CMI will be included in each carton.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines