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APO-Levetiracetam Oral levetiracetam 100 mg/mL amber glass bottle, Southern Cross Pharma Pty Ltd, CON-742
Product name
APO-Levetiracetam Oral levetiracetam 100 mg/mL amber glass bottle
Sponsor name
Southern Cross Pharma Pty Ltd
Batches
20705
Consent start
Consent no.
CON-742
Duration
The consent is effective from 28 January 2021 until batch 20705 is depleted.
Standard
Subparagraphs 8(1)(j)(iv)(A) and 8(1)(j)(iv)(B) 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)(iv)(A) and 8(1)(j)(iv)(B) of Therapeutic Goods Order No. 91 – Standard
for labels of prescription and related medicines (TGO 91) in that the carton and
bottle labels do not include the declaration for hydroxybenzoates as “Contains
hydroxybenzoates” as set out in column 4 of Schedule 1 of TGO 91 and does not
state the amount of maltitol “9 grams in 30 mL”.
Import, Supply, &/or Export
Import, supply and export
Therapeutic product type
Prescription medicines