Malta - English - Medicines Authority

viatris limited damastown industrial park, mulhuddart, dublin 15, dublin, ireland - film-coated tablet - quetiapine fumarate 100 mg - psycholeptics

Malta - English - Medicines Authority

viatris limited damastown industrial park, mulhuddart, dublin 15, dublin, ireland - film-coated tablet - quetiapine fumarate 200 mg - psycholeptics

Malta - English - Medicines Authority

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

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - buspirone hydrochloride 10mg;   - tablet - 10 mg - active: buspirone hydrochloride 10mg   excipient: colloidal anhydrous silica lactose monohydrate magnesium stearate microcrystalline cellulose sodium starch glycolate - buspirone hydrochloride is indicated for the management of anxiety disorders or the short-term relief of symptoms of anxiety with or without accompanying depression. the diagnosis of patients studied in controlled clinical trials of buspirone corresponds to the generalised anxiety disorder of the who classification as described below: generalised, persistent anxiety is manifested by symptoms from three of the following four categories: general tensions: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. autonomic hyperactivity: sweating, heart pounding or racing, cold clammy hands, dry mouth, dizziness, lightheadedness, paraesthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhoea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. apprehensive expectations: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. vigilance and scanning: hypertensiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling ?on edge?, irritability, impatience. the anxious mood has been continuous for at least one month. the ordinary anxiety and tension associated with the stress of everyday life usually does not require treatment with an anxiolytic agent. controlled clinical studies of buspirone have been limited to six months.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - buspirone hydrochloride 5mg;   - tablet - 5 mg - active: buspirone hydrochloride 5mg   excipient: colloidal anhydrous silica lactose monohydrate magnesium stearate microcrystalline cellulose sodium starch glycolate - buspirone hydrochloride is indicated for the management of anxiety disorders or the short-term relief of symptoms of anxiety with or without accompanying depression. the diagnosis of patients studied in controlled clinical trials of buspirone corresponds to the generalised anxiety disorder of the who classification as described below: generalised, persistent anxiety is manifested by symptoms from three of the following four categories: general tensions: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. autonomic hyperactivity: sweating, heart pounding or racing, cold clammy hands, dry mouth, dizziness, lightheadedness, paraesthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhoea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. apprehensive expectations: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. vigilance and scanning: hypertensiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling ?on edge?, irritability, impatience. the anxious mood has been continuous for at least one month. the ordinary anxiety and tension associated with the stress of everyday life usually does not require treatment with an anxiolytic agent. controlled clinical studies of buspirone have been limited to six months.

European Union - English - EMA (European Medicines Agency)

taw pharma (ireland) limited - clopidogrel hydrochloride - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - 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), ischaemic 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 - solifenacin succinate 10mg;   - film coated tablet - 10 mg - active: solifenacin succinate 10mg   excipient: hypromellose   iron oxide red iron oxide yellow lactose magnesium stearate maize starch propylene glycol purified talc titanium dioxide - solifenacin viatris is indicated for the treatment of unstable bladder with symptoms of increased urinary urgency, frequent microurination, and/or urge incontinence.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - solifenacin succinate 5mg;   - film coated tablet - 5 mg - active: solifenacin succinate 5mg   excipient: hypromellose   iron oxide yellow lactose magnesium stearate maize starch propylene glycol purified talc titanium dioxide - solifenacin viatris is indicated for the treatment of unstable bladder with symptoms of increased urinary urgency, frequent microurination, and/or urge incontinence.

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.

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

viatris pty ltd - fenofibrate, quantity: 48 mg - tablet - excipient ingredients: microcrystalline cellulose; sodium lauryl sulfate; lactose monohydrate; sucrose; hypromellose; docusate sodium; magnesium stearate; colloidal anhydrous silica; crospovidone; titanium dioxide; sunset yellow fcf aluminium lake; purified talc; xanthan gum; polyvinyl alcohol; quinoline yellow aluminium lake; lecithin; indigo carmine aluminium lake - fenofibrate viatris is indicated as an adjunct to diet in the treatment of: - hypercholesterolaemia; - types ii, iii, iv and v dyslipidaemia; - dyslipidaemia associated with type 2 diabetes.