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FLUANXOL DEPOT flupentixol decanoate 40 mg/2 mL injection ampoule, Lundbeck Australia Pty Ltd, CON-780
Product name
FLUANXOL DEPOT flupentixol decanoate 40 mg/2 mL injection ampoule
Sponsor name
Lundbeck Australia Pty Ltd
Batches
2682447, 2680047
Consent start
Consent no.
CON-780
Duration
The consent is effective from 15 April 2021 until 1 August 2021.
Standard
Paragraph 8(1)(n) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product packaging does not conform with the requirements of paragraph 8(1)(n) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the carton labels for the above mentioned batches include the incorrect Global Trade Item Number (GTIN) code in the 2D matrix and consequently, the GTIN codes within the 2D matrix and linear barcode on the carton are not identical.
Conditions imposed
A ‘Dear Healthcare Provider’ letter (as per the copy provided with the application) will be supplied with the affected batches outlining the non -compliance.
Import, Supply, &/or Export
Supply
Therapeutic product type
Prescription medicines