Australia - English - Department of Health (Therapeutic Goods Administration)

servier laboratories (aust) pty ltd - ivosidenib, quantity: 250 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; sodium lauryl sulfate; titanium dioxide; hypromellose; triacetin; indigo carmine aluminium lake; hypromellose acetate succinate; lactose monohydrate - cholangiocarcinoma,tibsovo is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (idh1) r132 mutation after at least one prior line of systemic therapy.,acute myeloid leukaemia,tibsovo is indicated for the treatment of acute myeloid leukaemia (aml) that carries an idh1 r132 mutation:,? as monotherapy, or in combination with azacitidine, in newly diagnosed patients who are not eligible to receive intensive induction chemotherapy; or,? as monotherapy in patients whose aml is relapsed and/or refractory to prior therapy.

United States - English - NLM (National Library of Medicine)

agios pharmaceuticals, inc. - ivosidenib (unii: q2pcn8mam6) (ivosidenib - unii:q2pcn8mam6) - tibsovo is indicated for the treatment of newly-diagnosed acute myeloid leukemia (aml) with a susceptible isocitrate dehydrogenase-1 (idh1) mutation as detected by an fda-approved test in adult patients who are ≥ 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy [see dosage and administration (2.1), clinical pharmacology (12.1) and clinical studies (14.1)]. tibsovo is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (aml) with a susceptible isocitrate dehydrogenase-1 (idh1) mutation as detected by an fda-approved test [see dosage and administration (2.1), clinical pharmacology (12.1) and clinical studies (14.2)]. none. risk summary based on animal embryo-fetal toxicity studies, tibsovo may cause fetal harm when administered to a pregnant woman. there are no available data on tibsovo use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. in animal embryo-fetal toxicity studies, ora

United States - English - NLM (National Library of Medicine)

servier pharmaceutical llc - ivosidenib (unii: q2pcn8mam6) (ivosidenib - unii:q2pcn8mam6) - tibsovo is indicated in combination with azacitidine or as monotherapy for the treatment of newly diagnosed acute myeloid leukemia (aml) with a susceptible isocitrate dehydrogenase-1 (idh1) mutation as detected by an fda-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy [see dosage and administration (2.1), clinical pharmacology (12.1) and clinical studies (14.1)]. tibsovo is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (aml) with a susceptible isocitrate dehydrogenase-1 (idh1) mutation as detected by an fda-approved test [see dosage and administration (2.1), clinical pharmacology (12.1) and clinical studies (14.2)] . tibsovo is indicated for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes (mds) with a susceptible isocitrate dehydrogenase-1 (idh1) mutation as detected by an fda-approved test [see dosage and administration (2.1), clinical pharmacolog

European Union - English - EMA (European Medicines Agency)

les laboratoires servier - ivosidenib - leukemia, myeloid, acute; cholangiocarcinoma - antineoplastic agents - tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) with an isocitrate dehydrogenase-1 (idh1) r132 mutation who are not eligible to receive standard induction chemotherapy (see section 5.1).tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an idh1 r132 mutation who were previously treated by at least one prior line of systemic therapy.

Bangladesh - English - DGDA (Directorate General of Drug Administration)

everest pharmaceuticals ltd. - ivosidenib - tablet - 250 mg

New Zealand - English - 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.

New Zealand - English - 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.

New Zealand - English - 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.

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - nirmatrelvir, ritonavir - covid-19 virus infection - paxlovid is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe covid 19.

Israel - English - Ministry of Health

teva israel ltd - atazanavir as sulfate - capsules - atazanavir as sulfate 200 mg - atazanavir - atazanavir teva ® is indicated in combination with other antiretroviral agents for for the treatment of hiv-1 infection.