Europos Sąjunga - anglų - 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).

Naujoji Zelandija - anglų - Medsafe (Medicines Safety Authority)

viatris limited - atazanavir sulfate 170.85mg equivalent to atazanavir 150mg; atazanavir sulfate 170.85mg equivalent to atazanavir 150mg - capsule - 150 mg - active: atazanavir sulfate 170.85mg equivalent to atazanavir 150mg excipient: crospovidone gelatin   iron oxide red lactose monohydrate magnesium stearate patent blue v   purified water   tekprint black sw-9008 titanium dioxide   active: atazanavir sulfate 170.85mg equivalent to atazanavir 150mg excipient: brilliant blue fcf   crospovidone erythrosine gelatin iron oxide yellow lactose monohydrate magnesium stearate purified water   titanium dioxide   - atazanavir viatris is indicated for the treatment of hiv 1 infection, in combination with other antiretroviral agents, in adult patients and in paediatric patients 6 to 18 years of age. this indication is based on analyses of plasma hiv-1 rna levels and cd4 cell counts from controlled studies.

Naujoji Zelandija - anglų - Medsafe (Medicines Safety Authority)

viatris limited - atazanavir sulfate 227.8mg equivalent to atazanavir 200mg; atazanavir sulfate 227.8mg equivalent to atazanavir 200mg - capsule - 200 mg - active: atazanavir sulfate 227.8mg equivalent to atazanavir 200mg excipient: brilliant blue fcf   crospovidone erythrosine gelatin   lactose monohydrate magnesium stearate purified water   titanium dioxide   active: atazanavir sulfate 227.8mg equivalent to atazanavir 200mg excipient: crospovidone gelatin   indigo carmine iron oxide yellow lactose monohydrate magnesium stearate patent blue v purified water   tekprint black sw-9008 titanium dioxide   - atazanavir viatris is indicated for the treatment of hiv 1 infection, in combination with other antiretroviral agents, in adult patients and in paediatric patients 6 to 18 years of age. this indication is based on analyses of plasma hiv-1 rna levels and cd4 cell counts from controlled studies.

Naujoji Zelandija - anglų - Medsafe (Medicines Safety Authority)

viatris limited - atazanavir sulfate 341.7mg equivalent to atazanavir 300mg; atazanavir sulfate 341.7mg equivalent to atazanavir 300mg - capsule - 300 mg - active: atazanavir sulfate 341.7mg equivalent to atazanavir 300mg excipient: brilliant blue fcf crospovidone erythrosine gelatin   iron oxide red iron oxide yellow lactose monohydrate magnesium stearate purified water   titanium dioxide   active: atazanavir sulfate 341.7mg equivalent to atazanavir 300mg excipient: crospovidone gelatin   iron oxide red   iron oxide yellow lactose monohydrate magnesium stearate patent blue v purified water   tekprint black sw-9008 titanium dioxide   - atazanavir viatris is indicated for the treatment of hiv 1 infection, in combination with other antiretroviral agents, in adult patients and in paediatric patients 6 to 18 years of age. this indication is based on analyses of plasma hiv-1 rna levels and cd4 cell counts from controlled studies.

Europos Sąjunga - anglų - 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.

Naujoji Zelandija - anglų - 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.

Naujoji Zelandija - anglų - 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.

Naujoji Zelandija - anglų - 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.

Naujoji Zelandija - anglų - 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.

Malta - anglų - Medicines Authority

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