European Union - English - EMA (European Medicines Agency)

merck sharp dohme ltd - laropiprant, nicotinic acid - dyslipidemias - lipid modifying agents - pelzont is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of low-density-lipoprotein (ldl) cholesterol and triglycerides and low high-density-lipoprotein (hdl)cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial).pelzont should be used in patients in combination with 3-hydroxy-3-methylglutaryl-coenzyme-a (hmg-coa)-reductase inhibitors (statins), when the cholesterol lowering effect of hmg-coa-reductase inhibitor monotherapy is inadequate. it can be used as monotherapy only in patients in whom hmg-coa-reductase inhibitors are considered inappropriate or not tolerated. diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with pelzont.

European Union - English - EMA (European Medicines Agency)

merck sharp dohme ltd. - laropiprant, nicotinic acid - dyslipidemias - lipid modifying agents - tredaptive is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of low-density-lipoprotein (ldl) cholesterol and triglycerides and low high-density-lipoprotein (hdl) cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial).tredaptive should be used in patients in combination with 3-hydroxy-3-methyl-glutaryl-co-enzyme-a (hmg-coa)-reductase inhibitors (statins), when the cholesterol-lowering effect of hmg-coa-reductase inhibitor monotherapy is inadequate. it can be used as monotherapy only in patients in whom hmg-coa-reductase inhibitors are considered inappropriate or not tolerated. diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with tredaptive.

European Union - English - EMA (European Medicines Agency)

merck sharp dohme ltd - laropiprant, nicotinic acid - dyslipidemias - lipid modifying agents - trevaclyn is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of low-density-lipoprotein (ldl) cholesterol and triglycerides and low high-density-lipoprotein (hdl) cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial).trevaclyn should be used in patients in combination with 3-hydroxy-3-methyl-glutaryl-co-enzyme-a (hmg-coa)-reductase inhibitors (statins), when the cholesterol-lowering effect of hmg-coa-reductase-inhibitor monotherapy is inadequate. it can be used as monotherapy only in patients in whom hmg-coa-reductase inhibitors are considered inappropriate or not tolerated. diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with trevaclyn.

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - interferon alfa-2b 15 miu/ml - solution for injection - 18 miu - active: interferon alfa-2b 15 miu/ml excipient: dibasic sodium phosphate disodium edetate dihydrate metacresol monobasic sodium phosphate monohydrate polysorbate 80 sodium chloride water for injection - intron a redipen is used in the treatment of: · hairy cell leukaemia in splenectomised or non-splenectomised patients; · chronic myelogenous leukaemia;

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - interferon alfa-2b 25 miu/ml - solution for injection - 30 miu - active: interferon alfa-2b 25 miu/ml excipient: dibasic sodium phosphate disodium edetate dihydrate metacresol monobasic sodium phosphate monohydrate polysorbate 80 sodium chloride water for injection - intron a redipen is used in the treatment of: · hairy cell leukaemia in splenectomised or non-splenectomised patients; · chronic myelogenous leukaemia;

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - interferon alfa-2b 50 miu/ml - solution for injection - 60 miu - active: interferon alfa-2b 50 miu/ml excipient: dibasic sodium phosphate disodium edetate dihydrate metacresol monobasic sodium phosphate monohydrate polysorbate 80 sodium chloride water for injection - intron a redipen is used in the treatment of: · hairy cell leukaemia in splenectomised or non-splenectomised patients; · chronic myelogenous leukaemia;

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.