New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - laropiprant 20mg;  ; nicotinic acid 1000mg - tablet - active: laropiprant 20mg   nicotinic acid 1000mg excipient: colloidal silicon dioxide croscarmellose sodium hyprolose hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose sodium stearyl fumarate

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 - 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.

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.

Canada - English - Health Canada

sunovion pharmaceuticals canada inc - nicotinic acid - tablet (extended-release) - 1000mg - nicotinic acid 1000mg - miscellaneous antilipemic agents

Canada - English - Health Canada

sunovion pharmaceuticals canada inc - nicotinic acid - tablet (extended-release) - 1000mg - nicotinic acid 1000mg - miscellaneous antilipemic agents

Canada - English - Health Canada

sunovion pharmaceuticals canada inc - nicotinic acid - tablet (extended-release) - 500mg - nicotinic acid 500mg - miscellaneous antilipemic agents

Canada - English - Health Canada

sunovion pharmaceuticals canada inc - nicotinic acid - tablet (extended-release) - 500mg - nicotinic acid 500mg - miscellaneous antilipemic agents

Canada - English - Health Canada

sunovion pharmaceuticals canada inc - nicotinic acid - tablet (extended-release) - 750mg - nicotinic acid 750mg - miscellaneous antilipemic agents

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

torrent australasia pty ltd - simvastatin, quantity: 20 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: microcrystalline cellulose; propyl gallate; croscarmellose sodium; hypromellose; butylated hydroxyanisole; lactose monohydrate; ascorbic acid; ferric oxide; citric acid monohydrate; magnesium stearate - adults (greater than or equal to 18 years),prevention of cardiovascular disease,ezetorin 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,ezetorin 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),ezetorin is indicated in patients with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).,childre