Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
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
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'.
Therapeutic product type
Prescription medicines