New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - rosuvastatin calcium 10.396mg equivalent to rosuvastatin 10 mg - film coated tablet - 10 mg - active: rosuvastatin calcium 10.396mg equivalent to rosuvastatin 10 mg excipient: colloidal silicon dioxide crospovidone iron oxide red lactose monohydrate light magnesium oxide magnesium stearate microcrystalline cellulose opadry pink - rosuvastatin calcium is indicated to: · reduce elevated ldl-c, total cholesterol, triglycerides and to increase hdlcholesterol in patients with primary hypercholesterolemia (heterozygous familial and non familial) and mixed dyslipidaemia (fredrickson types iia and iib). rosuvastatin calcium also lowers apob, nonhdl-c, vldl-c, vldl-tg, the ldl-c/hdl-c, total c/hdl-c, nonhdl-c/hdl-c, apob/apoa-i ratios and increase apo-a-i in these populations. · treat isolated hypertriglyceridaemia (fredrickson type iv hyperlipidaemia). · reduce total cholesterol and ldl-c in patients with homozygous familial hypercholesterolemia, as an adjunct to diet and other lipid lowering treatments (e.g. ldl apheresis) or alone if such treatments are unavailable.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - rosuvastatin calcium 20.792mg equivalent to rosuvastatin 20 mg - film coated tablet - 20 mg - active: rosuvastatin calcium 20.792mg equivalent to rosuvastatin 20 mg excipient: colloidal silicon dioxide crospovidone iron oxide red lactose monohydrate light magnesium oxide magnesium stearate microcrystalline cellulose opadry pink - rosuvastatin calcium is indicated to: · reduce elevated ldl-c, total cholesterol, triglycerides and to increase hdlcholesterol in patients with primary hypercholesterolemia (heterozygous familial and non familial) and mixed dyslipidaemia (fredrickson types iia and iib). rosuvastatin calcium also lowers apob, nonhdl-c, vldl-c, vldl-tg, the ldl-c/hdl-c, total c/hdl-c, nonhdl-c/hdl-c, apob/apoa-i ratios and increase apo-a-i in these populations. · treat isolated hypertriglyceridaemia (fredrickson type iv hyperlipidaemia). · reduce total cholesterol and ldl-c in patients with homozygous familial hypercholesterolemia, as an adjunct to diet and other lipid lowering treatments (e.g. ldl apheresis) or alone if such treatments are unavailable.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - rosuvastatin calcium 41.584mg equivalent to rosuvastatin 40 mg - film coated tablet - 40 mg - active: rosuvastatin calcium 41.584mg equivalent to rosuvastatin 40 mg excipient: colloidal silicon dioxide crospovidone iron oxide red lactose monohydrate light magnesium oxide magnesium stearate microcrystalline cellulose opadry pink - rosuvastatin calcium is indicated to: · reduce elevated ldl-c, total cholesterol, triglycerides and to increase hdlcholesterol in patients with primary hypercholesterolemia (heterozygous familial and non familial) and mixed dyslipidaemia (fredrickson types iia and iib). rosuvastatin calcium also lowers apob, nonhdl-c, vldl-c, vldl-tg, the ldl-c/hdl-c, total c/hdl-c, nonhdl-c/hdl-c, apob/apoa-i ratios and increase apo-a-i in these populations. · treat isolated hypertriglyceridaemia (fredrickson type iv hyperlipidaemia). · reduce total cholesterol and ldl-c in patients with homozygous familial hypercholesterolemia, as an adjunct to diet and other lipid lowering treatments (e.g. ldl apheresis) or alone if such treatments are unavailable.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - rosuvastatin calcium 5.198mg equivalent to rosuvastatin 5 mg - film coated tablet - 5 mg - active: rosuvastatin calcium 5.198mg equivalent to rosuvastatin 5 mg excipient: colloidal silicon dioxide crospovidone iron oxide red lactose monohydrate light magnesium oxide magnesium stearate microcrystalline cellulose opadry yellow - rosuvastatin calcium is indicated to: · reduce elevated ldl-c, total cholesterol, triglycerides and to increase hdlcholesterol in patients with primary hypercholesterolemia (heterozygous familial and non familial) and mixed dyslipidaemia (fredrickson types iia and iib). rosuvastatin calcium also lowers apob, nonhdl-c, vldl-c, vldl-tg, the ldl-c/hdl-c, total c/hdl-c, nonhdl-c/hdl-c, apob/apoa-i ratios and increase apo-a-i in these populations. · treat isolated hypertriglyceridaemia (fredrickson type iv hyperlipidaemia). · reduce total cholesterol and ldl-c in patients with homozygous familial hypercholesterolemia, as an adjunct to diet and other lipid lowering treatments (e.g. ldl apheresis) or alone if such treatments are unavailable.

New Zealand - English - Medsafe (Medicines Safety Authority)

aurobindo pharma nz limited - simvastatin 10mg;   - film coated tablet - 10 mg - active: simvastatin 10mg   excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate starch, pregelatinised (starch 1500) lactose monohydrate magnesium stearate microcrystalline cellulose opadry pink 20a54239 - paediatric patients with heterozygous familial hypercholesterolaemia: simvastatin is indicated as an adjunct to diet to reduce total-c, ldl-c, tg, and apo b levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh).

New Zealand - English - Medsafe (Medicines Safety Authority)

aurobindo pharma nz limited - simvastatin 20mg;   - film coated tablet - 20 mg - active: simvastatin 20mg   excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate starch, pregelatinised (starch 1500) lactose monohydrate magnesium stearate microcrystalline cellulose opadry pink 20a54239 - paediatric patients with heterozygous familial hypercholesterolaemia: simvastatin is indicated as an adjunct to diet to reduce total-c, ldl-c, tg, and apo b levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh).

New Zealand - English - Medsafe (Medicines Safety Authority)

aurobindo pharma nz limited - simvastatin 40mg;   - film coated tablet - 40 mg - active: simvastatin 40mg   excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate starch, pregelatinised (starch 1500) lactose monohydrate magnesium stearate microcrystalline cellulose opadry pink 20a54211 - paediatric patients with heterozygous familial hypercholesterolaemia: simvastatin is indicated as an adjunct to diet to reduce total-c, ldl-c, tg, and apo b levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh).

New Zealand - English - Medsafe (Medicines Safety Authority)

aurobindo pharma nz limited - simvastatin 5mg;   - film coated tablet - 5 mg - active: simvastatin 5mg   excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate lactose monohydrate magnesium stearate microcrystalline cellulose opadry yellow 20a52229 starch - paediatric patients with heterozygous familial hypercholesterolaemia: simvastatin is indicated as an adjunct to diet to reduce total-c, ldl-c, tg, and apo b levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh).

New Zealand - English - Medsafe (Medicines Safety Authority)

aurobindo pharma nz limited - simvastatin 80mg;   - film coated tablet - 80 mg - active: simvastatin 80mg   excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate starch, pregelatinised (starch 1500) lactose monohydrate magnesium stearate microcrystalline cellulose opadry pink 20a54211 - paediatric patients with heterozygous familial hypercholesterolaemia: simvastatin is indicated as an adjunct to diet to reduce total-c, ldl-c, tg, and apo b levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh).

Australia - English - Department of Health (Therapeutic Goods Administration)

torrent australasia pty ltd - simvastatin, quantity: 80 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: lactose monohydrate; propyl gallate; croscarmellose sodium; butylated hydroxyanisole; ascorbic acid; citric acid monohydrate; microcrystalline cellulose; hypromellose; magnesium stearate; ferric oxide - adults (greater than or equal to 18 years),prevention of cardiovascular disease,apo-ezetimine/simvastatin is 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 (see section 5.1 pharmacodynamic properties - clinical trials),primary hypercholesterolaemia,apo-ezetimine/simvastatin is 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),apo-ezetimine/simvastatin is indicated in patients with hofh. patients may also receive