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EZETIMIBE/ATORVASTATIN SANDOZ 10/10, EZETIMIBE/ATORVASTATIN SANDOZ 10/20, EZETIMIBE/ATORVASTATIN SANDOZ 10/40, EZETIMIBE/ATORVASTATIN SANDOZ 10/80 (Sandoz Pty Ltd)

Product name
EZETIMIBE/ATORVASTATIN SANDOZ 10/10, EZETIMIBE/ATORVASTATIN SANDOZ 10/20, EZETIMIBE/ATORVASTATIN SANDOZ 10/40, EZETIMIBE/ATORVASTATIN SANDOZ 10/80
Sponsor
Sandoz Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
174 (255 working days)
Active ingredients
Atorvastatin calcium trihydrate, Ezetimibe
Registration type
New generic medicine
Indication
Prevention of cardiovascular disease

EZETIMIBE/ATORVASTATIN SANDOZ 10/10, EZETIMIBE/ATORVASTATIN SANDOZ 10/20, EZETIMIBE/ATORVASTATIN SANDOZ 10/40, EZETIMIBE/ATORVASTATIN SANDOZ 10/80 (tablet) is 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 (see Section 5.1 Pharmacodynamic Properties, Clinical trials).

Primary hypercholesterolaemia

EZETIMIBE/ATORVASTATIN SANDOZ 10/10, EZETIMIBE/ATORVASTATIN SANDOZ 10/20, EZETIMIBE/ATORVASTATIN SANDOZ 10/40, EZETIMIBE/ATORVASTATIN SANDOZ 10/80 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 SANDOZ 10/10, EZETIMIBE/ATORVASTATIN SANDOZ 10/20, EZETIMIBE/ATORVASTATIN SANDOZ 10/40, EZETIMIBE/ATORVASTATIN SANDOZ 10/80 is indicated in patients with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis).

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