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EZETIMIBE LUPIN, EZETIMIBE LAPL, EZETIMIBE GH (Lupin Australia Pty Limited)
Product name
EZETIMIBE LUPIN, EZETIMIBE LAPL, EZETIMIBE GH
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
40 working days (255)
Active ingredients
ezetimibe
Registration type
EOI
Indication
Generic medicine
EZETIMIBE LUPIN, EZETIMIBE LAPL and EZETIMIBE GH (tablets), in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit, is now also indicated for the prevention of cardiovascular disease in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy.