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).

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)

viatris limited - simvastatin 20mg;  ;   - film coated tablet - 20 mg - active: simvastatin 20mg     excipient: ascorbic acid butylated hydroxytoluene citric acid monohydrate colloidal silicon dioxide hypromellose iron oxide red iron oxide yellow isopropyl alcohol lactose monohydrate macrogol 400 magnesium stearate maize starch microcrystalline cellulose pregelatinised maize starch purified talc purified water   sodium starch glycolate titanium dioxide - patients at high risk of coronary heart disease (chd) or with existing chd. in patients at high risk of chd (with or without hyperlipidaemia but with a total cholesterol >3.5mmol/l), i.e. patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd, simvastatin is indicated to: · reduce the risk of total mortality by reducing chd deaths · reduce the risk of major vascular events (a composite of non-fatal myocardial infarction, chd death, stroke, or revascularisation procedures · reduce the risk of major coronary events (a composite of non-fatal myocardial infarction or chd deaths) · reduce the risk of stroke · reduce the need for coronary revascularisation procedures (including coronary artery bypass grafting and percutaneous transluminal coronary angioplasty) · reduce the need for peripheral and other non-coronary revascularisation procedures · reduce the risk of hospitalisation for angina pectoris in patients with diabetes, simvastatin reduces the risk of developing peripheral macrovascular complications (a composite of peripheral revascularisation procedures, lower limb amputations or leg ulcers). in hypercholesterolaemic patients with coronary heart disease, simvastatin slows the progression of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions.

United States - English - NLM (National Library of Medicine)

legacy pharmaceutical packaging, llc - simvastatin (unii: agg2fn16ev) (simvastatin - unii:agg2fn16ev) - simvastatin 20 mg - simvastatin tablets usp are indicated: - to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. - as an adjunct to diet to reduce low-density lipoprotein cholesterol (ldl-c): - in adults with primary hyperlipidemia. - in adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (hefh). - as an adjunct to other ldl-c-lowering therapies to reduce ldl-c in adults with homozygous familial hypercholesterolemia (hofh). - as an adjunct to diet for the treatment of adults with: - primary dysbetalipoproteinemia. - hypertriglyceridemia. simvastatin is contraindicated in the following conditions: - concomitant use of strong cyp3a4 inhibitors (select azole a

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

arrotex pharmaceuticals pty ltd - simvastatin, quantity: 10 mg - tablet, film coated - excipient ingredients: ascorbic acid; lactose monohydrate; citric acid monohydrate; microcrystalline cellulose; butylated hydroxyanisole; magnesium stearate; pregelatinised maize starch; 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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bristol laboratories ltd - simvastatin - oral tablet - 20mg

Canada - English - Health Canada

apotex inc - simvastatin - tablet - 20mg - simvastatin 20mg - hmg-coa reductase inhibitors

Canada - English - Health Canada

sun pharma canada inc - simvastatin - tablet - 20mg - simvastatin 20mg - hmg-coa reductase inhibitors

Canada - English - Health Canada

jamp pharma corporation - simvastatin - tablet - 20mg - simvastatin 20mg - hmg-coa reductase inhibitors

Canada - English - Health Canada

mint pharmaceuticals inc - simvastatin - tablet - 20mg - simvastatin 20mg - hmg-coa reductase inhibitors