Malta - English - Medicines Authority

viatris limited damastown industrial park, mulhuddart, dublin 15, dublin, ireland - hard capsule - dabigatran etexilate 150 mg - antithrombotic agents

European Union - English - EMA (European Medicines Agency)

mylan ireland limited - rivaroxaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antithrombotic agents - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers. rivaroxaban mylan co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery. treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults.-------adults prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment. 

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - zoledronic acid monohydrate 0.8528 mg/ml equivalent to zoledronic acid 0.8 mg/ml;   - concentrate for infusion - 4 mg/5ml - active: zoledronic acid monohydrate 0.8528 mg/ml equivalent to zoledronic acid 0.8 mg/ml   excipient: hydrochloric acid sodium citrate sodium hydroxide water for injection - · treatment of tumour-induced hypercalcaemia.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - bisoprolol fumarate 10mg - film coated tablet - 10 mg - active: bisoprolol fumarate 10mg excipient: colloidal silicon dioxide croscarmellose sodium stear-o-wet m or ligamed mf bls-mb (magnesium stearate/sodium lauryl sulphate (94/6)) iron oxide red lactose microcrystalline cellulose opadry orange 40c83047 - treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ace inhibitors, and diuretics, and optionally cardiac glycosides.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - bisoprolol fumarate 2.5mg - film coated tablet - 2.5 mg - active: bisoprolol fumarate 2.5mg excipient: colloidal silicon dioxide croscarmellose sodium stear-o-wet m or ligamed mf bls-mb (magnesium stearate/sodium lauryl sulphate (94/6)) iron oxide red iron oxide yellow lactose microcrystalline cellulose opadry grey 40c57557 - treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ace inhibitors, and diuretics, and optionally cardiac glycosides.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - bisoprolol fumarate 5mg - film coated tablet - 5 mg - active: bisoprolol fumarate 5mg excipient: colloidal silicon dioxide croscarmellose sodium stear-o-wet m or ligamed mf bls-mb (magnesium stearate/sodium lauryl sulphate (94/6)) iron oxide yellow lactose microcrystalline cellulose opadry yellow 40c82321 - treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ace inhibitors, and diuretics, and optionally cardiac glycosides.

Ireland - English - HPRA (Health Products Regulatory Authority)

viatris limited - amlodipine besilate - tablet - dihydropyridine derivatives; amlodipine

Ireland - English - HPRA (Health Products Regulatory Authority)

viatris limited - amlodipine besilate - tablet - dihydropyridine derivatives; amlodipine

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.