Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

viatris limited - pravastatin sodium 10mg;   - tablet - 10 mg - active: pravastatin sodium 10mg   excipient: croscarmellose sodium iron oxide yellow lactose monohydrate light magnesium oxide magnesium stearate microcelac 100 povidone - pravastatin is indicated: · in hypercholesterolemic patients without clinically evident coronary heart disease, as an adjunct to diet to reduce the risk of fatal and non-fatal myocardial infarction, need for myocardial revascularisation procedures, and to improve survival by reducing cardiovascular deaths. · for the reduction of elevated total and ldl-cholesterol levels in patients with primary hypercholesterolaemia when the response to diet and other nonpharmacological measures alone have been inadequate. · as an adjunct to diet to slow the progressive course of atherosclerosis and reduce the incidence of clinical cardiovascular events in hypercholesterolaemic men under 75 years of age with coronary artery disease. · coronary artery disease: in patients with a history of either a myocardial infarction or unstable angina pectoris to reduce the risk for total mortality, chd death, recurrent coronary event (including myocardial infarction), need for myocardial revascularisation procedures, and need for hospitalisation. · cerebrovascular disease: in patients with a history of coronary artery disease (i.e. either a myocardial infarction or unstable angina pectoris) to reduce the risk of stroke or transient ischemic attacks (tias). · cardiac and renal transplantation: in patients receiving immunosuppressive therapy to improve survival in cardiac transplant patients and to reduce the risk of acute rejection in kidney transplant patients

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

viatris limited - pravastatin sodium 20mg;   - tablet - 20 mg - active: pravastatin sodium 20mg   excipient: croscarmellose sodium iron oxide yellow lactose monohydrate light magnesium oxide magnesium stearate microcelac 100 povidone - pravastatin is indicated: · in hypercholesterolemic patients without clinically evident coronary heart disease, as an adjunct to diet to reduce the risk of fatal and non-fatal myocardial infarction, need for myocardial revascularisation procedures, and to improve survival by reducing cardiovascular deaths. · for the reduction of elevated total and ldl-cholesterol levels in patients with primary hypercholesterolaemia when the response to diet and other nonpharmacological measures alone have been inadequate. · as an adjunct to diet to slow the progressive course of atherosclerosis and reduce the incidence of clinical cardiovascular events in hypercholesterolaemic men under 75 years of age with coronary artery disease. · coronary artery disease: in patients with a history of either a myocardial infarction or unstable angina pectoris to reduce the risk for total mortality, chd death, recurrent coronary event (including myocardial infarction), need for myocardial revascularisation procedures, and need for hospitalisation. · cerebrovascular disease: in patients with a history of coronary artery disease (i.e. either a myocardial infarction or unstable angina pectoris) to reduce the risk of stroke or transient ischemic attacks (tias). · cardiac and renal transplantation: in patients receiving immunosuppressive therapy to improve survival in cardiac transplant patients and to reduce the risk of acute rejection in kidney transplant patients

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

viatris limited - pravastatin sodium 40mg;   - tablet - 40 mg - active: pravastatin sodium 40mg   excipient: croscarmellose sodium iron oxide yellow lactose monohydrate light magnesium oxide magnesium stearate microcelac 100 povidone - pravastatin is indicated: · in hypercholesterolemic patients without clinically evident coronary heart disease, as an adjunct to diet to reduce the risk of fatal and non-fatal myocardial infarction, need for myocardial revascularisation procedures, and to improve survival by reducing cardiovascular deaths. · for the reduction of elevated total and ldl-cholesterol levels in patients with primary hypercholesterolaemia when the response to diet and other nonpharmacological measures alone have been inadequate. · as an adjunct to diet to slow the progressive course of atherosclerosis and reduce the incidence of clinical cardiovascular events in hypercholesterolaemic men under 75 years of age with coronary artery disease. · coronary artery disease: in patients with a history of either a myocardial infarction or unstable angina pectoris to reduce the risk for total mortality, chd death, recurrent coronary event (including myocardial infarction), need for myocardial revascularisation procedures, and need for hospitalisation. · cerebrovascular disease: in patients with a history of coronary artery disease (i.e. either a myocardial infarction or unstable angina pectoris) to reduce the risk of stroke or transient ischemic attacks (tias). · cardiac and renal transplantation: in patients receiving immunosuppressive therapy to improve survival in cardiac transplant patients and to reduce the risk of acute rejection in kidney transplant patients

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

viatris limited - dosulepin hydrochloride 75mg; dosulepin hydrochloride 75mg; dosulepin hydrochloride 75mg - film coated tablet - 75 mg - active: dosulepin hydrochloride 75mg excipient: carnauba wax clear film coat 5544 + colour film coat 5553 lactose monohydrate magnesium stearate maize starch povidone purified talc sodium starch glycolate active: dosulepin hydrochloride 75mg excipient: carnauba wax diethyl phthalate ethanol hypromellose lactose monohydrate magnesium stearate maize starch opaspray red k-1f-4972 povidone purified talc purified water sodium starch glycolate active: dosulepin hydrochloride 75mg excipient: opadry red oy-b-25005 lactose monohydrate magnesium stearate maize starch povidone purified talc sodium starch glycolate - depression of any aetiology and the anxiety frequently associated with depressive illness.

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

viatris limited - dexmedetomidine hydrochloride 0.118 mg/ml equivalent to dexmedetomidine 0.100mg/ml;   - concentrate for infusion - 200 mcg/2ml - active: dexmedetomidine hydrochloride 0.118 mg/ml equivalent to dexmedetomidine 0.100mg/ml   excipient: sodium chloride water for injection - icu sedation: for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine viatris by continuous infusion in these patients should not exceed 24 hours. procedural sedation: for sedation of non-intubated patients prior to and/or during surgical and other procedures.

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

viatris limited - domperidone maleate 12.72mg equivalent to domperidone 10 mg - tablet - 10 mg - active: domperidone maleate 12.72mg equivalent to domperidone 10 mg excipient: colloidal silicon dioxide lactose monohydrate magnesium stearate maize starch microcrystalline cellulose povidone purified water sodium laurilsulfate - treatment of acute symptoms of nausea and vomiting.

Irska - engleski - HPRA (Health Products Regulatory Authority)

viatris limited - vancomycin - powder for solution for infusion - glycopeptide antibacterials; vancomycin

Irska - engleski - HPRA (Health Products Regulatory Authority)

viatris limited - tiotropium - inhalation powder, hard capsule - tiotropium bromide

Irska - engleski - HPRA (Health Products Regulatory Authority)

viatris limited - vancomycin - powder for solution for infusion - glycopeptide antibacterials; vancomycin

Novi Zeland - engleski - 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.