New Zealand - Inggeris - 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.

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

viatris limited - tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245mg - film coated tablet - 300 mg - active: tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245mg excipient: colloidal silicon dioxide hyprolose lactose monohydrate magnesium stearate microcrystalline cellulose opadry blue 32k505018 - tenofovir disoproxil mylan is indicated for the treatment of chronic hepatitis b in adults and paediatric patients 12 years of age and older.

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

viatris limited - tobramycin 80mg - solution for injection - 80 mg/2ml - active: tobramycin 80mg excipient: disodium edetate sodium bisulfate sodium hydroxide sulfuric acid water for injection - tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: - septicaemia in the neonate, child, and adult caused by p aeruginosa, e coli, and klebsiella sp - lower respiratory tract infections caused by p aeruginosa, klebsiella sp, enterobacter sp, serratia sp, e coli, and s aureus (penicillinase and non-penicillinase-producing strains) - serious central-nervous-system infections (meningitis) caused by susceptible organisms - intra-abdominal infections, including peritonitis, caused by e coli, klebsiella sp, and enterobacter sp - skin, bone, and skin-structure infections (including burns) caused by p aeruginosa, proteus sp, e coli, klebsiella sp, enterobacter sp, and s aureus - complicated and recurrent urinary tract infections caused by p aeruginosa, proteus sp (indole-positive and indole-negative), e coli, klebsiella sp, enterobacter sp, serratia sp, s aureus, providencia sp, and citrobacter sp.

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

viatris limited - valganciclovir hydrochloride 496.3mg equivalent to valganciclovir 450 mg - film coated tablet - 450 mg - active: valganciclovir hydrochloride 496.3mg equivalent to valganciclovir 450 mg excipient: crospovidone microcrystalline cellulose opadry brown 15b565009 purified water stearic acid - for the treatment of cytomegalovirus (cmv) retinitis in acquired immunodeficiency syndrome (aids) patients. for the prevention of cmv disease in solid organ transplant patients at risk.

New Zealand - Inggeris - 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.

Australia - Inggeris - 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.

United Kingdom - Inggeris - MHRA (Medicines & Healthcare Products Regulatory Agency)

viatris uk healthcare ltd - cetirizine hydrochloride - oral tablet - 10mg

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

viatris limited - dexmedetomidine hydrochloride 0.118 mg/ml equivalent to dexmedetomidine 0.100mg/ml;   - concentrate for infusion - 200 mcg/2ml - active: dexmedetomidine hydrochloride 0.118 mg/ml equivalent to dexmedetomidine 0.100mg/ml   excipient: sodium chloride water for injection - icu sedation: for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine viatris by continuous infusion in these patients should not exceed 24 hours. procedural sedation: for sedation of non-intubated patients prior to and/or during surgical and other procedures.

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

viatris limited - bisacodyl 5mg - enteric coated tablet - 5 mg - active: bisacodyl 5mg excipient: carnauba wax hyprolose hypromellose methacrylic acid copolymer, eudragit s 100 iron oxide yellow isopropyl alcohol lactose monohydrate magnesium stearate   methacrylic acid copolymer microcrystalline cellulose purified talc purified water   starch sucrose titanium dioxide triethyl citrate - short term relief of constipation

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

viatris limited - metoprolol tartrate 5mg - solution for injection - 5 mg/5ml - active: metoprolol tartrate 5mg excipient: sodium chloride water for injection - disturbances of cardiac rhythm, including supraventricular and ventricular arrhythmias.