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.

Malta - English - Medicines Authority

viatris limited damastown industrial park, mulhuddart, dublin 15, dublin, ireland - powder for solution for infusion - piperacillin 2 g tazobactam 0.25 g - antibacterials for systemic use

Malta - English - Medicines Authority

viatris limited damastown industrial park, mulhuddart, dublin 15, dublin, ireland - powder for solution for infusion - tazobactam 0.5 g piperacillin 4 g - antibacterials for systemic use

Ireland - English - HPRA (Health Products Regulatory Authority)

viatris limited - linagliptin - film-coated tablet - linagliptin

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - atenolol 100mg; atenolol 100mg - film coated tablet - 100 mg - active: atenolol 100mg excipient: colloidal silicon dioxide hypromellose macrogol 6000 magnesium carbonate magnesium stearate maize starch purified talc sodium laurilsulfate sodium starch glycolate sunset yellow aluminium lake titanium dioxide active: atenolol 100mg excipient: colloidal silicon dioxide hypromellose macrogol 6000 magnesium carbonate magnesium stearate maize starch purified talc purified water sodium laurilsulfate sodium starch glycolate titanium dioxide - control of hypertension.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - atenolol 50mg; atenolol 50mg - film coated tablet - 50 mg - active: atenolol 50mg excipient: colloidal silicon dioxide hypromellose macrogol 6000 magnesium carbonate magnesium stearate maize starch purified talc sodium laurilsulfate sodium starch glycolate sunset yellow aluminium lake titanium dioxide active: atenolol 50mg excipient: colloidal silicon dioxide hypromellose macrogol 6000 magnesium carbonate magnesium stearate maize starch purified talc purified water sodium laurilsulfate sodium starch glycolate titanium dioxide - control of hypertension.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - midazolam 1 mg/ml;   - solution for injection - 1 mg/ml - active: midazolam 1 mg/ml   excipient: hydrochloric acid sodium chloride sodium hydroxide water for injection - conscious sedation before diagnostic or surgical interventions carried out under local anaesthesia (intravenous administration), or in children intranasal or oral administration. long-term sedation in intensive care units (intravenous administration as bolus injection or continuous infusion).

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - midazolam 5 mg/ml;   - solution for injection - 5 mg/ml - active: midazolam 5 mg/ml   excipient: hydrochloric acid sodium chloride sodium hydroxide water for injection - conscious sedation before diagnostic or surgical interventions carried out under local anaesthesia (intravenous administration), or in children intranasal or oral administration. long-term sedation in intensive care units (intravenous administration as bolus injection or continuous infusion).