Australia - English - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - oxycodone hydrochloride, quantity: 5 mg - tablet, uncoated - excipient ingredients: lactose; microcrystalline cellulose; stearic acid - oxycodone viatris is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Australia - English - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - betahistine dihydrochloride, quantity: 16 mg - tablet, uncoated - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; mannitol; citric acid monohydrate; purified talc - meniere's syndrome as defined by the following core symptoms: - vertigo (with nausea/vomiting): - hearing loss (hardness of hearing): - tinnitus.

Australia - English - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - moxonidine, quantity: 400 microgram - tablet, film coated - excipient ingredients: crospovidone; lactose monohydrate; ethylcellulose; titanium dioxide; povidone; macrogol 6000; hypromellose; purified talc; magnesium stearate; iron oxide red - for the treatment of hypertension.

Australia - English - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - moxonidine, quantity: 200 microgram - tablet, film coated - excipient ingredients: magnesium stearate; macrogol 6000; povidone; ethylcellulose; crospovidone; purified talc; iron oxide red; titanium dioxide; hypromellose; lactose monohydrate - for the treatment of hypertension.

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 - 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.

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.

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.

Australia - English - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - fluticasone propionate, quantity: 50 microgram/actuation; azelastine hydrochloride, quantity: 137 microgram/actuation (equivalent: azelastine, qty 125 microgram/actuation) - spray, nasal - excipient ingredients: phenethyl alcohol; benzalkonium chloride; purified water; microcrystalline cellulose; polysorbate 80; carmellose sodium; glycerol; disodium edetate - symptomatic treatment of moderate to severe allergic rhinitis for up to 6 months.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - methyldopa sesquihydrate 283mg equivalent to to 250 mg methyldopa anhydrous;   - tablet - 250 mg - active: methyldopa sesquihydrate 283mg equivalent to to 250 mg methyldopa anhydrous   excipient: citric acid   colloidal silicon dioxide disodium edetate dihydrate ethylcellulose guar gum magnesium stearate opadry yellow oy-8462 purified water sodium starch glycolate - hypertension (mild, moderate or severe).