爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

viatris limited - atorvastatin calcium trihydrate - film-coated tablet - hmg coa reductase inhibitors; atorvastatin

马耳他 - 英文 - Medicines Authority

viatris limited damastown industrial park, mulhuddart, dublin 15, dublin, ireland - hard capsule - dabigatran etexilate 75 mg - antithrombotic agents

新西兰 - 英文 - Medsafe (Medicines Safety Authority)

viatris limited - montelukast sodium 4.15mg equivalent to montelukast 4 mg - chewable tablet - 4 mg - active: montelukast sodium 4.15mg equivalent to montelukast 4 mg excipient: aspartame cherry flavour 501027 ap0551 colloidal silicon dioxide croscarmellose sodium stear-o-wet m mannitol microcrystalline cellulose - indicated in paediatric patients 2 to 5 years of age for the relief of daytime and night-time symptoms of seasonal allergic rhinitis and perennial allergic rhinitis.

新西兰 - 英文 - Medsafe (Medicines Safety Authority)

viatris limited - montelukast sodium 5.19mg equivalent to montelukast 5 mg - chewable tablet - 5 mg - active: montelukast sodium 5.19mg equivalent to montelukast 5 mg excipient: aspartame cherry flavour 501027 ap0551 colloidal silicon dioxide croscarmellose sodium stear-o-wet m mannitol microcrystalline cellulose - indicated in paediatric patients 6 to 14 years of age for the relief of daytime and night-time symptoms of seasonal allergic rhinitis and perennial allergic rhinitis.

新西兰 - 英文 - Medsafe (Medicines Safety Authority)

viatris limited - montelukast sodium 10.4mg equivalent to montelukast 10 mg - film coated tablet - 10 mg - active: montelukast sodium 10.4mg equivalent to montelukast 10 mg excipient: colloidal silicon dioxide croscarmellose sodium magnesium stearate mannitol microcrystalline cellulose opadry blue y-22-10538 opadry clear ys-1-7006 sodium laurilsulfate - indicated in adults 15 years of age and older for the relief of day-time and night-time symptoms of seasonal allergic rhinitis and perennial allergic rhinitis.

新西兰 - 英文 - Medsafe (Medicines Safety Authority)

viatris limited - zoledronic acid monohydrate 5.33mg equivalent to zolendronic acid (anhydrous) 5mg - solution for infusion - 5 mg/100ml - active: zoledronic acid monohydrate 5.33mg equivalent to zolendronic acid (anhydrous) 5mg excipient: mannitol sodium citrate water for injection - · treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures and to increase bone mineral density. · prevention of postmenopausal osteoporosis.

马耳他 - 英文 - Medicines Authority

viatris limited damastown industrial park, mulhuddart, dublin 15, dublin, ireland - hard capsule - dabigatran etexilate 110 mg - antithrombotic agents

马耳他 - 英文 - Medicines Authority

viatris limited damastown industrial park, mulhuddart, dublin 15, dublin, ireland - hard capsule - dabigatran etexilate 150 mg - antithrombotic agents

新西兰 - 英文 - 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.

新西兰 - 英文 - 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.