cetirizine hydrochloride (ZETRINE) 10 mg film coated tablet blister pack, Ipca Pharma (Australia) Pty Ltd, CON-90
Product name
cetirizine hydrochloride (ZETRINE) 10 mg film coated tablet blister pack
Sponsor name
Ipca Pharma (Australia) Pty Ltd
Consent start
Consent no.
CON-90
Standard
The products do not conform with the requirements of the Therapeutic Goods Order No. 78 'Standard for tablets and Capsules' in respect of Section 8.
Non-compliance with standard
The 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 product 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.
#160;
Therapeutic product type
Over-the-counter medicines