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APO-FENOFIBRATE fenofibrate 145 mg tablet blister pack, Southern Cross Pharma Pty Ltd, CON-743
Product name
APO-FENOFIBRATE fenofibrate 145 mg tablet blister pack
Sponsor name
Southern Cross Pharma Pty Ltd
Batches
32369, 32468 and 32469
Consent start
Consent no.
CON-743
Duration
The consent is effective from 29 January 2021 until batches 32369, 32468, 32469 and 32370 are depleted.
Standard
Subparagraphs 8(1)(j)(i) and 8(1)(j)(iv)(A) 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 subparagraphs
8(1)(j)(i) and 8(1)(j)(iv)(A) of Therapeutic Goods Order No. 91 – Standard for
labels of prescription and related medicines (TGO 91) in that the carton labels
for the batches listed above include the lactose declaration as “Contains
lactose” instead of “Contains sugars as lactose”.
Import, Supply, &/or Export
Supply
Therapeutic product type
Prescription medicines