CANDESARTAN GH candesartan cilexetil 16 mg tablet blister pack, Generic Health Pty Ltd, CON-198
Product name
CANDESARTAN GH candesartan cilexetil 16 mg tablet blister pack
Sponsor name
Generic Health Pty Ltd
ARTG
195485
Consent start
Consent no.
CON-198
Standard
USP monograph for Candesartan Cilexetil.
Non-compliance with standard
The candesartan 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