BLOOMS THE CHEMIST CANDESARTAN candesartan cilexetil 16 mg tablet blister pack, Apotex Pty Ltd, CON-189
Product name
BLOOMS THE CHEMIST CANDESARTAN candesartan cilexetil 16 mg tablet blister pack
Sponsor name
Apotex Pty Ltd
ARTG
260094
Consent start
Consent no.
CON-189
Standard
USP monograph for Candesartan Cilexetil Tablets (the default standard).
Non-compliance with standard
Theproductcandesartan impurity E content exceeds the USP monograph requirement
of NMT 0.2%.
Conditions imposed
The candesartan impurity E expiry limit in drug product is the same as that
currently approved (NMT 0.5%).
Therapeutic product type
Prescription medicines