Malta - English - Medicines Authority

viatris limited damastown industrial park, mulhuddart, dublin 15, dublin, ireland - film-coated tablet - quetiapine fumarate 300 mg - psycholeptics

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.

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 - darunavir 400mg; darunavir 400mg - film coated tablet - 400 mg - active: darunavir 400mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry orange 85f530014 sodium starch glycolate active: darunavir 400mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry white 85f18422 purified water   sodium starch glycolate - darunavir mylan (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 mylan (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.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - darunavir 600mg; darunavir 600mg - film coated tablet - 600 mg - active: darunavir 600mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry orange 85f93050 sodium starch glycolate active: darunavir 600mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry white 85f18422 purified water   sodium starch glycolate - darunavir mylan (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 mylan (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.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - emtricitabine 200mg;  ; tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg; emtricitabine 200mg; tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg - film coated tablet - 200 mg/300 mg - active: emtricitabine 200mg   tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg excipient: colloidal silicon dioxide hyprolose iron oxide red lactose monohydrate magnesium stearate microcrystalline cellulose opadry green 31k510010 active: emtricitabine 200mg tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg excipient: colloidal silicon dioxide hyprolose iron oxide red lactose monohydrate magnesium stearate microcrystalline cellulose opadry green 32k510087 - treatment of hiv-1 infection tenofovir disoproxil emtricitabine viatris is indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents.

Ireland - English - HPRA (Health Products Regulatory Authority)

viatris limited - rosuvastatin - film-coated tablet - hmg coa reductase inhibitors; rosuvastatin

Ireland - English - HPRA (Health Products Regulatory Authority)

viatris limited - rosuvastatin - film-coated tablet - hmg coa reductase inhibitors; rosuvastatin

Ireland - English - HPRA (Health Products Regulatory Authority)

viatris limited - rosuvastatin - film-coated tablet - hmg coa reductase inhibitors; rosuvastatin