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ORFADIN nitisinone 4 mg/mL oral suspension bottle, A Menarini Australia Pty Ltd , CON-1337
Product name
ORFADIN nitisinone 4 mg/mL oral suspension bottle
Sponsor name
A Menarini Australia Pty Ltd
Batches
8378758
Consent start
Consent no.
CON-1337
Duration
The consent is effective from 19 March 2025 until 30 June 2026.
Standard
Paragraph 8(1)(g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product has been labelled with a shelf life of 2 years, expiring in June
2025. The correct shelf life is 3 years and the expiry date is June 2026.
Conditions imposed
A ‘Dear Healthcare Professional’ letter will be supplied with each affected unit
describing the corrected shelf life.
Import, Supply, &/or Export
supply
Therapeutic product type
Prescription medicines