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EZESIM, EZETORIN, EZETREE, EZETYR, EZEVYT, EZSIMZA GH, EZTORSI, SIMTOR, SIMTORSI, TORZESIM (Torrent Australasia Pty Ltd)

Product name
EZESIM, EZETORIN, EZETREE, EZETYR, EZEVYT, EZSIMZA GH, EZTORSI, SIMTOR, SIMTORSI, TORZESIM
Date registered
Evaluation commenced
Decision date
Approval time
158 working days (255)
Active ingredients
ezetimibe; simvastatin
Registration type
New generic medicine
Indication
Adults (≥18 years)
Prevention of Cardiovascular Disease

EZESIM, EZETORIN, EZETREE, EZETYR, EZEVYT, EZSIMZA GH, EZTORSI, SIMTOR, SIMTORSI, TORZESIM (tablets) are indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of simvastatin 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

EZESIM, EZETORIN, EZETREE, EZETYR, EZEVYT, EZSIMZA GH, EZTORSI, SIMTOR, SIMTORSI, TORZESIM are indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate:

  • Patients not appropriately controlled with a statin or ezetimibe alone.
  • Patients already treated with a statin and ezetimibe.
Homozygous Familial Hypercholesterolaemia (HoFH)

EZESIM, EZETORIN, EZETREE, EZETYR, EZEVYT, EZSIMZA GH, EZTORSI, SIMTOR, SIMTORSI, TORZESIM are indicated in patients with HoFH. Patients may also receive adjunctive treatments (eg. LDL apheresis).

Children and Adolescents 10-17 years

(pubertal status: boys Tanner Stage II and above and girls who are at least one year post-menarche)

Heterozygous Familial Hypercholesterolaemia (HeFH)

EZESIM, EZETORIN, EZETREE, EZETYR, EZEVYT, EZSIMZA GH, EZTORSI, SIMTOR, SIMTORSI, TORZESIM are indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:

  • Patients not appropriately controlled with a statin or ezetimibe alone.
  • Patients already treated with a statin and ezetimibe.
Homozygous Familial Hypercholesterolaemia (HoFH)

EZESIM, EZETORIN, EZETREE, EZETYR, EZEVYT, EZSIMZA GH, EZTORSI, SIMTOR, SIMTORSI, TORZESIM are indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (eg. LDL apheresis).

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