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APO-FENOFIBRATE, FENOFIBRATE AJS, BLOOMS THE CHEMIST FENOFIBRATE, FENOFIBRATE APOTEX, FENOFIBRATE SCP (Southern Cross Pharma Pty Ltd)
Product name
APO-FENOFIBRATE, FENOFIBRATE AJS, BLOOMS THE CHEMIST FENOFIBRATE, FENOFIBRATE APOTEX, FENOFIBRATE SCP
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
246 working days (255)
Active ingredients
fenofibrate
Registration type
New generic medicine
Indication
APO-FENOFIBRATE, FENOFIBRATE AJS, BLOOMS THE CHEMIST FENOFIBRATE, FENOFIBRATE APOTEX, FENOFIBRATE SCP (tablets) are indicated as an adjunct to diet in the treatment of:
- hypercholesterolaemia;
- types II, III, IV and V dyslipidaemia;
- dyslipidaemia associated with type 2 diabetes
APO-FENOFIBRATE, FENOFIBRATE AJS, BLOOMS THE CHEMIST FENOFIBRATE, FENOFIBRATE APOTEX, FENOFIBRATE SCP is indicated for the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy. Fenofibrate does not replace the appropriate control of blood pressure, blood glucose and blood lipids in reducing the progression of diabetic retinopathy.