European Union - English - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - drugs used in diabetes - type 2 diabetes mellitusdapagliflozin viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance.- in addition to other medicinal products for the treatment of type 2 diabetes.for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.

European Union - English - EMA (European Medicines Agency)

viatris limited - pirfenidone - idiopathic pulmonary fibrosis; lung diseases; respiratory tract diseases - immunosuppressants - pirfenidone viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

European Union - English - EMA (European Medicines Agency)

viatris limited - clopidogrel besilate - peripheral vascular diseases; stroke; myocardial infarction - antithrombotic agents - secondary prevention of atherothrombotic events clopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.adult patients suffering from acute coronary syndrome.non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa).st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy.in patients with moderate to high-risk transient ischaemic attack (tia) or minor ischaemic stroke (is) clopidogrel in combination with asa is indicated in:adult patients with moderate to high-risk tia (abcd2 score ≥4) or minor is (nihss ≤3) within 24 hours of either the tia or is event.prevention of atherothrombotic and thromboembolic events in atrial fibrillation:in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke.for further information please refer to section 5.1.

New Zealand - English - 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.

New Zealand - English - 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.

New Zealand - English - 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.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

viatris sdn. bhd. - amlodipine besylate -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

viatris sdn. bhd. - amlodipine besylate -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

viatris sdn. bhd. - eplerenone -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

viatris sdn. bhd. - eplerenone -