新西兰 - 英文 - 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.

欧盟 - 英文 - EMA (European Medicines Agency)

viatris healthcare limited - fenofibrate, simvastatin - dyslipidemias - lipid modifying agents - cholib is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase hdl c levels when ldl c levels are adequately controlled with the corresponding dose of simvastatin monotherapy.

新西兰 - 英文 - 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.

新西兰 - 英文 - 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.

新西兰 - 英文 - 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.

新西兰 - 英文 - 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.

新西兰 - 英文 - 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.

新西兰 - 英文 - 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.

新西兰 - 英文 - Medsafe (Medicines Safety Authority)

viatris limited - tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245mg - film coated tablet - 300 mg - active: tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245mg excipient: colloidal silicon dioxide hyprolose lactose monohydrate magnesium stearate microcrystalline cellulose opadry blue 32k505018 - tenofovir disoproxil mylan is indicated for the treatment of chronic hepatitis b in adults and paediatric patients 12 years of age and older.

新西兰 - 英文 - Medsafe (Medicines Safety Authority)

viatris limited - tobramycin 80mg - solution for injection - 80 mg/2ml - active: tobramycin 80mg excipient: disodium edetate sodium bisulfate sodium hydroxide sulfuric acid water for injection - tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: - septicaemia in the neonate, child, and adult caused by p aeruginosa, e coli, and klebsiella sp - lower respiratory tract infections caused by p aeruginosa, klebsiella sp, enterobacter sp, serratia sp, e coli, and s aureus (penicillinase and non-penicillinase-producing strains) - serious central-nervous-system infections (meningitis) caused by susceptible organisms - intra-abdominal infections, including peritonitis, caused by e coli, klebsiella sp, and enterobacter sp - skin, bone, and skin-structure infections (including burns) caused by p aeruginosa, proteus sp, e coli, klebsiella sp, enterobacter sp, and s aureus - complicated and recurrent urinary tract infections caused by p aeruginosa, proteus sp (indole-positive and indole-negative), e coli, klebsiella sp, enterobacter sp, serratia sp, s aureus, providencia sp, and citrobacter sp.