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.

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.

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - aripiprazole - schizophrenia; bipolar disorder - psycholeptics - aripiprazole mylan pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.aripiprazole mylan pharma is indicated for the treatment of moderate to severe manic episodes in bipolar i disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.aripiprazole mylan pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in bipolar i disorder in adolescents aged 13 years and older.

Malta - English - Medicines Authority

viatris limited damastown industrial park, mulhuddart, dublin 15, dublin, ireland - film-coated tablet - quetiapine fumarate 25 mg - psycholeptics

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.