Israel - English - Ministry of Health

dexcel pharma technologies ltd - simvastatin - caplets - simvastatin 80 mg - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvaxon is indicated to: reduce the risk of total mortality by reducing coronary death reduce the risk of non-fatal myocardial infarction reduce the risk for undergoing myocardial revascularization procedures.reduce the risk of stroke and transient ischemic attacks (tia). hyperlipidemia: simvaxon is indicated as an adjunct to diet to reduce elevated total-c ldl-c apo b and tg and to increase hdl-c in patients with primary hypercholesterolemia( heterozygous familial and nonfamilial) and mixed dyslipidemia (frederickson types iia and iib) simvaxon therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios. homozygous familial hypercholesterolemia: simvaxon is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol ldl-cholesterol and apolipoprotein b in patients with homozygous familial hypercholesterolemia when response to these measures is inadequate. hypertriglyceridemia (fredrickson type iv hyperlipidemia). simvaxon is indicated for the treatment of patients with primary dysbetalipoproteinemia (fredrickson type iii hyperlipidemia).in patients at a high risk of coronary events because of existing coronary heart disease diabetes peripheral vessel disease history of stroke or other cerebrovascular disease simvaxon is indicated to: - reduce the risk of total mortality by reducing chd deaths. - reduce the risk of non-fatal myocardial infarction and stroke. - reduce the need for coronary and non-coronary revascularization procedures

Israel - English - Ministry of Health

dexcel pharma technologies ltd - simvastatin - caplets - simvastatin 40 mg - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvaxon is indicated to: - reduce the risk of total mortality by reducing coronary death - reduce the risk of non-fatal myocardial infarction - reduce the risk for undergoing myocardial revascularization procedures - reduce the risk of stroke and transient ischemic attacks (tia's). hyperlipidemia: simvaxon is indicated as an adjunct to diet to reduce elevated total-c ldl-c apo b and tg and to increase hdl-c in patients with primary hypercholesterolemia ( heterozygous familial and nonfamilial) and mixed dyslipidemia (frederickson types iia and iib) simvaxon therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios. homozygous familial hypercholesterolemia: simvaxon is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol ldl-cholesterol and apolipoprotein b in patients with homozygous familial hypercholesterolemia when response to these measure

Israel - English - Ministry of Health

dexcel pharma technologies ltd - simvastatin - caplets - simvastatin 10 mg - simvastatin - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvaxon is indicated to: - reduce the risk of total mortality by reducing coronary death - reduce the risk of non-fatal myocardial infarction - reduce the risk for undergoing myocardial revascularization procedures - reduce the risk of stroke and transient ischemic attacks (tia's). hyperlipidemia: simvaxon is indicated as an adjunct to diet to reduce elevated total-c ldl-c apo b and tg and to increase hdl-c in patients with primary hypercholesterolemia ( heterozygous familial and nonfamilial) and mixed dyslipidemia (frederickson types iia and iib) simvaxon therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios. homozygous familial hypercholesterolemia: simvaxon is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol ldl-cholesterol and apolipoprotein b in patients with homozygous familial hypercholesterolemia when response to these measures is inadequate. hypertriglyceridemia (fredrickson type iv hyperlipidemia): simvaxon is indicated for the treatment of patients with hypertriglyceridemia (fredrickson type iv hyperlipidemia). dysbetalipoproteinemia (fredrickson type iii hyperlipidemia): simvaxon is indicated for the treatment of patients with primary dysbetalipoproteinemia (fredrickson type iii hyperlipidemia).

Israel - English - Ministry of Health

dexcel pharma technologies ltd - simvastatin - caplets - simvastatin 40 mg - simvastatin - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvaxon is indicated to: - reduce the risk of total mortality by reducing coronary death - reduce the risk of non-fatal myocardial infarction - reduce the risk for undergoing myocardial revascularization procedures - reduce the risk of stroke and transient ischemic attacks (tia's). hyperlipidemia: simvaxon is indicated as an adjunct to diet to reduce elevated total-c ldl-c apo b and tg and to increase hdl-c in patients with primary hypercholesterolemia ( heterozygous familial and nonfamilial) and mixed dyslipidemia (frederickson types iia and iib) simvaxon therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios. homozygous familial hypercholesterolemia: simvaxon is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol ldl-cholesterol and apolipoprotein b in patients with homozygous familial hypercholesterolemia when response to these measures is inadequate. hypertriglyceridemia (fredrickson type iv hyperlipidemia): simvaxon is indicated for the treatment of patients with hypertriglyceridemia (fredrickson type iv hyperlipidemia). dysbetalipoproteinemia (fredrickson type iii hyperlipidemia): simvaxon is indicated for the treatment of patients with primary dysbetalipoproteinemia (fredrickson type iii hyperlipidemia).

Israel - English - Ministry of Health

dexcel pharma technologies ltd - simvastatin - caplets - simvastatin 20 mg - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvaxon is indicated to: - reduce the risk of total mortality by reducing coronary death - reduce the risk of non-fatal myocardial infarction - reduce the risk for undergoing myocardial revascularization procedures - reduce the risk of stroke and transient ischemic attacks (tia's). hyperlipidemia: simvaxon is indicated as an adjunct to diet to reduce elevated total-c ldl-c apo b and tg and to increase hdl-c in patients with primary hypercholesterolemia ( heterozygous familial and nonfamilial) and mixed dyslipidemia (frederickson types iia and iib) simvaxon therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios. homozygous familial hypercholesterolemia: simvaxon is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol ldl-cholesterol and apolipoprotein b in patients with homozygous familial hypercholesterolemia when response to these measures is inadequate. hypertriglyceridemia (fredrickson type iv hyperlipidemia): simvaxon is indicated for the treatment of patients with hypertriglyceridemia (fredrickson type iv hyperlipidemia). dysbetalipoproteinemia (fredrickson type iii hyperlipidemia): simvaxon is indicated for the treatment of patients with primary dysbetalipoproteinemia (fredrickson type iii hyperlipidemia).

Egypt - English - EDA (Egyptian Drug Authority)

pharma de france-egypt - coated tablet

Egypt - English - EDA (Egyptian Drug Authority)

pharma de france-egypt - coated tablet

Egypt - English - EDA (Egyptian Drug Authority)

pharma de france-egypt - tablet

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

arrotex pharmaceuticals pty ltd - simvastatin, quantity: 10 mg - tablet, film coated - excipient ingredients: magnesium stearate; butylated hydroxyanisole; microcrystalline cellulose; lactose monohydrate; pregelatinised maize starch; ascorbic acid; citric acid monohydrate; titanium dioxide; hypromellose; hyprolose; purified talc; iron oxide yellow; iron oxide red; iron oxide black - simvastatin is indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (eg poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. simvastatin is indicated in patients at high risk of chd (coronary heart disease) (with or without hypercholesterolaemia), including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

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).