FENOFIBRATE GENERICHEALTH (Lupin Australia Pty Limited)
Product name
FENOFIBRATE GENERICHEALTH
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
138 (255 working days
Active ingredients
Fenofibrate
Registration type
New generic medicine
Indication
Fenofibrate GH Tablets, Fenofibrate Generichealth Tablets and Fenofibrate LAPL Tablets is indicated as an adjunct to diet in the treatment of:
- hypercholesterolaemia;
- types II, III, IV and V dyslipidaemia;
- dyslipidaemia associated with type 2 diabetes.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine