نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

viatris limited - methyldopa sesquihydrate 283mg equivalent to to 250 mg methyldopa anhydrous;   - tablet - 250 mg - active: methyldopa sesquihydrate 283mg equivalent to to 250 mg methyldopa anhydrous   excipient: citric acid   colloidal silicon dioxide disodium edetate dihydrate ethylcellulose guar gum magnesium stearate opadry yellow oy-8462 purified water sodium starch glycolate - hypertension (mild, moderate or severe).

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

viatris limited - simvastatin 10mg;  ;   - film coated tablet - 10 mg - active: simvastatin 10mg     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.

نيوزيلاندا - الإنجليزية - 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.

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

viatris limited - simvastatin 40mg;  ;   - film coated tablet - 40 mg - active: simvastatin 40mg     excipient: ascorbic acid butylated hydroxytoluene citric acid monohydrate colloidal silicon dioxide hypromellose iron oxide red 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.

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

viatris limited - simvastatin 80mg;  ;   - film coated tablet - 80 mg - active: simvastatin 80mg     excipient: ascorbic acid butylated hydroxytoluene citric acid monohydrate colloidal silicon dioxide hypromellose iron oxide red isopropyl alcohol lactose monohydrate macrogol 400 magnesium stearate maize starch microcrystalline cellulose purified talc purified water   sodium starch glycolate starch 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.

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

viatris limited - darunavir 300mg; darunavir 300mg - film coated tablet - 300 mg - active: darunavir 300mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry orange 85f93050 sodium starch glycolate active: darunavir 300mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry white 85f18422 purified water   sodium starch glycolate - darunavir viatris (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients. darunavir viatris (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged greater than or equal to 6 years old and weighing at least 40 kg.

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

viatris limited - metformin hydrochloride 500mg;  ;  ; metformin hydrochloride 500mg - film coated tablet - 500 mg - active: metformin hydrochloride 500mg     excipient: dri-klear magnesium stearate povidone active: metformin hydrochloride 500mg excipient: magnesium stearate opadry clear 20c59060 povidone - · treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control · metformin may be used as initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents. · adjuvant therapy in insulin dependent diabetes especially if overweight.

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

viatris limited - metformin hydrochloride 850mg;  ;  ; metformin hydrochloride 850mg - film coated tablet - 850 mg - active: metformin hydrochloride 850mg     excipient: dri-klear magnesium stearate povidone active: metformin hydrochloride 850mg excipient: magnesium stearate opadry clear 20c59060 povidone - · treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control · metformin may be used as initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents. · adjuvant therapy in insulin dependent diabetes especially if overweight.

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

viatris limited - montelukast sodium 4.15mg equivalent to montelukast 4 mg - chewable tablet - 4 mg - active: montelukast sodium 4.15mg equivalent to montelukast 4 mg excipient: aspartame cherry flavour 501027 ap0551 colloidal silicon dioxide croscarmellose sodium stear-o-wet m mannitol microcrystalline cellulose - indicated in paediatric patients 2 to 5 years of age for the relief of daytime and night-time symptoms of seasonal allergic rhinitis and perennial allergic rhinitis.

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

viatris limited - montelukast sodium 5.19mg equivalent to montelukast 5 mg - chewable tablet - 5 mg - active: montelukast sodium 5.19mg equivalent to montelukast 5 mg excipient: aspartame cherry flavour 501027 ap0551 colloidal silicon dioxide croscarmellose sodium stear-o-wet m mannitol microcrystalline cellulose - indicated in paediatric patients 6 to 14 years of age for the relief of daytime and night-time symptoms of seasonal allergic rhinitis and perennial allergic rhinitis.