New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - buspirone hydrochloride 5mg;   - tablet - 5 mg - active: buspirone hydrochloride 5mg   excipient: colloidal anhydrous silica lactose monohydrate magnesium stearate microcrystalline cellulose sodium starch glycolate - buspirone hydrochloride is indicated for the management of anxiety disorders or the short-term relief of symptoms of anxiety with or without accompanying depression. the diagnosis of patients studied in controlled clinical trials of buspirone corresponds to the generalised anxiety disorder of the who classification as described below: generalised, persistent anxiety is manifested by symptoms from three of the following four categories: general tensions: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. autonomic hyperactivity: sweating, heart pounding or racing, cold clammy hands, dry mouth, dizziness, lightheadedness, paraesthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhoea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. apprehensive expectations: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. vigilance and scanning: hypertensiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling ?on edge?, irritability, impatience. the anxious mood has been continuous for at least one month. the ordinary anxiety and tension associated with the stress of everyday life usually does not require treatment with an anxiolytic agent. controlled clinical studies of buspirone have been limited to six months.

New Zealand - English - 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).

New Zealand - English - 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.

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.

New Zealand - English - 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.

New Zealand - English - 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.

New Zealand - English - 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.

New Zealand - English - 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.

New Zealand - English - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - montelukast sodium 10.4mg equivalent to montelukast 10 mg - film coated tablet - 10 mg - active: montelukast sodium 10.4mg equivalent to montelukast 10 mg excipient: colloidal silicon dioxide croscarmellose sodium magnesium stearate mannitol microcrystalline cellulose opadry blue y-22-10538 opadry clear ys-1-7006 sodium laurilsulfate - indicated in adults 15 years of age and older for the relief of day-time and night-time symptoms of seasonal allergic rhinitis and perennial allergic rhinitis.