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EZETIMIBE/ATORVASTATIN GENERICHEALTH, EZETIMIBE/ATORVASTATIN GH, EZETIMIBE/ATORVASTATIN LAPL (Lupin Australia Pty Limited)

Product name
EZETIMIBE/ATORVASTATIN GENERICHEALTH, EZETIMIBE/ATORVASTATIN GH, EZETIMIBE/ATORVASTATIN LAPL
Sponsor
Lupin Australia Pty Limited
Date registered
Evaluation commenced
Decision date
Approval time
202 working days (255)
Active ingredients
ezetimibe; atorvastatin
Registration type
New generic medicine
Indication
Prevention of Cardiovascular Disease

EZETIMIBE/ATORVASTATIN GENERICHEALTH, EZETIMIBE/ATORVASTATIN GH, EZETIMIBE/ATORVASTATIN LAPL (tablets) are indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of atorvastatin and 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

Primary Hypercholesterolaemia

Ezetimibe/Atorvastatin is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients:

  • not appropriately controlled with atorvastatin or ezetimibe alone; or
  • already treated with atorvastatin and ezetimibe.
Homozygous Familial Hypercholesterolaemia (HoFH)

Ezetimibe/Atorvastatin is indicated in patients with HoFH. Patients may also receive adjunctive treatments (eg. LDL apheresis).

Registration process

First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine

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