Namibia - English - Namibia Medicines Regulatory Council

msd (pty) ltd - niacin; laropiprant - tablet - each tablet contains 1 g extended -; release(er) niacin (nicotinic acid), immediate-release laropiprant 20,0 mg

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).

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - simvastatin 10mg - film coated tablet - 10 mg - active: simvastatin 10mg excipient: ascorbic acid butylated hydroxyanisole carnauba wax citric acid monohydrate hyprolose hypromellose iron oxide red iron oxide yellow lactose monohydrate magnesium stearate microcrystalline cellulose pregelatinised maize starch purified talc 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 of >3.5 mmol/l), ie., patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd, lipex 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, lipex 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, lipex slows the progression of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions.

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - simvastatin 20mg - film coated tablet - 20 mg - active: simvastatin 20mg excipient: ascorbic acid butylated hydroxyanisole carnauba wax citric acid monohydrate hyprolose hypromellose iron oxide red iron oxide yellow lactose monohydrate magnesium stearate microcrystalline cellulose pregelatinised maize starch purified talc 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 of >3.5 mmol/l), ie., patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd, lipex 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, lipex 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, lipex slows the progression of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions.

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - simvastatin 40mg - film coated tablet - 40 mg - active: simvastatin 40mg excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate hyprolose hypromellose iron oxide red lactose monohydrate magnesium stearate microcrystalline cellulose pregelatinised maize starch purified talc 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 of >3.5 mmol/l), ie., patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd, lipex 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, lipex 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, lipex slows the progression of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions.

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - simvastatin 5mg - film coated tablet - 5 mg - active: simvastatin 5mg excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate hyprolose hypromellose iron oxide yellow lactose monohydrate magnesium stearate microcrystalline cellulose pregelatinised maize starch purified talc 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 of >3.5 mmol/l), ie., patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd, lipex 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, lipex 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, lipex slows the progression of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions.