यूरोपीय संघ - अंग्रेज़ी - 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).

यूरोपीय संघ - अंग्रेज़ी - 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.

न्यूज़ीलैंड - अंग्रेज़ी - 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.

न्यूज़ीलैंड - अंग्रेज़ी - Medsafe (Medicines Safety Authority)

viatris limited - rosuvastatin calcium 10.396mg equivalent to rosuvastatin 10 mg - film coated tablet - 10 mg - active: rosuvastatin calcium 10.396mg equivalent to rosuvastatin 10 mg excipient: colloidal silicon dioxide crospovidone iron oxide red lactose monohydrate light magnesium oxide magnesium stearate microcrystalline cellulose opadry pink - rosuvastatin calcium is indicated to: · reduce elevated ldl-c, total cholesterol, triglycerides and to increase hdlcholesterol in patients with primary hypercholesterolemia (heterozygous familial and non familial) and mixed dyslipidaemia (fredrickson types iia and iib). rosuvastatin calcium also lowers apob, nonhdl-c, vldl-c, vldl-tg, the ldl-c/hdl-c, total c/hdl-c, nonhdl-c/hdl-c, apob/apoa-i ratios and increase apo-a-i in these populations. · treat isolated hypertriglyceridaemia (fredrickson type iv hyperlipidaemia). · reduce total cholesterol and ldl-c in patients with homozygous familial hypercholesterolemia, as an adjunct to diet and other lipid lowering treatments (e.g. ldl apheresis) or alone if such treatments are unavailable.

न्यूज़ीलैंड - अंग्रेज़ी - Medsafe (Medicines Safety Authority)

viatris limited - rosuvastatin calcium 20.792mg equivalent to rosuvastatin 20 mg - film coated tablet - 20 mg - active: rosuvastatin calcium 20.792mg equivalent to rosuvastatin 20 mg excipient: colloidal silicon dioxide crospovidone iron oxide red lactose monohydrate light magnesium oxide magnesium stearate microcrystalline cellulose opadry pink - rosuvastatin calcium is indicated to: · reduce elevated ldl-c, total cholesterol, triglycerides and to increase hdlcholesterol in patients with primary hypercholesterolemia (heterozygous familial and non familial) and mixed dyslipidaemia (fredrickson types iia and iib). rosuvastatin calcium also lowers apob, nonhdl-c, vldl-c, vldl-tg, the ldl-c/hdl-c, total c/hdl-c, nonhdl-c/hdl-c, apob/apoa-i ratios and increase apo-a-i in these populations. · treat isolated hypertriglyceridaemia (fredrickson type iv hyperlipidaemia). · reduce total cholesterol and ldl-c in patients with homozygous familial hypercholesterolemia, as an adjunct to diet and other lipid lowering treatments (e.g. ldl apheresis) or alone if such treatments are unavailable.

न्यूज़ीलैंड - अंग्रेज़ी - Medsafe (Medicines Safety Authority)

viatris limited - rosuvastatin calcium 41.584mg equivalent to rosuvastatin 40 mg - film coated tablet - 40 mg - active: rosuvastatin calcium 41.584mg equivalent to rosuvastatin 40 mg excipient: colloidal silicon dioxide crospovidone iron oxide red lactose monohydrate light magnesium oxide magnesium stearate microcrystalline cellulose opadry pink - rosuvastatin calcium is indicated to: · reduce elevated ldl-c, total cholesterol, triglycerides and to increase hdlcholesterol in patients with primary hypercholesterolemia (heterozygous familial and non familial) and mixed dyslipidaemia (fredrickson types iia and iib). rosuvastatin calcium also lowers apob, nonhdl-c, vldl-c, vldl-tg, the ldl-c/hdl-c, total c/hdl-c, nonhdl-c/hdl-c, apob/apoa-i ratios and increase apo-a-i in these populations. · treat isolated hypertriglyceridaemia (fredrickson type iv hyperlipidaemia). · reduce total cholesterol and ldl-c in patients with homozygous familial hypercholesterolemia, as an adjunct to diet and other lipid lowering treatments (e.g. ldl apheresis) or alone if such treatments are unavailable.

न्यूज़ीलैंड - अंग्रेज़ी - Medsafe (Medicines Safety Authority)

viatris limited - rosuvastatin calcium 5.198mg equivalent to rosuvastatin 5 mg - film coated tablet - 5 mg - active: rosuvastatin calcium 5.198mg equivalent to rosuvastatin 5 mg excipient: colloidal silicon dioxide crospovidone iron oxide red lactose monohydrate light magnesium oxide magnesium stearate microcrystalline cellulose opadry yellow - rosuvastatin calcium is indicated to: · reduce elevated ldl-c, total cholesterol, triglycerides and to increase hdlcholesterol in patients with primary hypercholesterolemia (heterozygous familial and non familial) and mixed dyslipidaemia (fredrickson types iia and iib). rosuvastatin calcium also lowers apob, nonhdl-c, vldl-c, vldl-tg, the ldl-c/hdl-c, total c/hdl-c, nonhdl-c/hdl-c, apob/apoa-i ratios and increase apo-a-i in these populations. · treat isolated hypertriglyceridaemia (fredrickson type iv hyperlipidaemia). · reduce total cholesterol and ldl-c in patients with homozygous familial hypercholesterolemia, as an adjunct to diet and other lipid lowering treatments (e.g. ldl apheresis) or alone if such treatments are unavailable.

न्यूज़ीलैंड - अंग्रेज़ी - 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).

न्यूज़ीलैंड - अंग्रेज़ी - Medsafe (Medicines Safety Authority)

viatris limited - darunavir 400mg; darunavir 400mg - film coated tablet - 400 mg - active: darunavir 400mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry orange 85f530014 sodium starch glycolate active: darunavir 400mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry white 85f18422 purified water   sodium starch glycolate - darunavir viatris (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients. darunavir viatris (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged greater than or equal to 6 years old and weighing at least 40 kg.

न्यूज़ीलैंड - अंग्रेज़ी - Medsafe (Medicines Safety Authority)

viatris limited - darunavir 600mg; darunavir 600mg - film coated tablet - 600 mg - active: darunavir 600mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry orange 85f93050 sodium starch glycolate active: darunavir 600mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry white 85f18422 purified water   sodium starch glycolate - darunavir viatris (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients. darunavir viatris (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged greater than or equal to 6 years old and weighing at least 40 kg.