Cetirizine hydrochloride (PRICELINE CETIRIZINE) 10mg tablet blister pack, Dr Reddys Laboratories Australia Pty Ltd, CON-93
Product name
Cetirizine hydrochloride (PRICELINE CETIRIZINE) 10mg tablet blister pack
Sponsor name
Dr Reddys Laboratories Australia Pty Ltd
ARTG
157094
Consent start
Consent no.
CON-93
Standard
The requirements of the Therapeutic Goods Order No. 78 'Standard for tablets and Capsules' in respect of Section 8.
Non-compliance with standard
Finished product specifications do not meet the requirements of the current
British Pharmacopoeia (BP) monograph for Cetirizine Tablets with respect to the
'area of any other secondary peak' in the test for Related Substances.
Conditions imposed
The release and expiry limits applied to the lactose-ester impurity in the
finished products specifications are those detailed in the request dated 19 May
2016; consistent with the relevant requirements of the United States
Pharmacopeia monograph for Cetirizine Hydrochloride Tablets.
Therapeutic product type
Over-the-counter medicines