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APO-FENOFIBRATE fenofibrate 48 mg tablet blister pack, Southern Cross Pharma Pty Ltd, CON-751
Product name
APO-FENOFIBRATE fenofibrate 48 mg tablet blister pack
Sponsor name
Southern Cross Pharma Pty Ltd
Batches
33092 33093
Consent start
Consent no.
CON-751
Duration
The consent is effective for the listed batches from 9 February 2021 until the batches 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 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
Import, supply and export
Therapeutic product type
Prescription medicines