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

exelixis, inc. - cabozantinib s-malate (unii: dr7st46x58) (cabozantinib - unii:1c39jw444g) - cabozantinib 80 mg - cometriq is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (mtc). none risk summary based on findings from animal studies and its mechanism of action, cometriq can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data in pregnant women to inform the drug-associated risk. in animal developmental and reproductive toxicology studies administration of cabozantinib to pregnant rats and rabbits during organogenesis resulted in embryofetal lethality and structural anomalies at exposures that were below those occurring clinically at the recommended dose (see data ) . advise pregnant women or women of childbearing potential of the potential hazard to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is

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

exelixis, inc. - cabozantinib s-malate (unii: dr7st46x58) (cabozantinib - unii:1c39jw444g) - cabozantinib 60 mg - cabometyx is indicated for the treatment of patients with advanced renal cell carcinoma (rcc). cabometyx, in combination with nivolumab, is indicated for the first-line treatment of patients with advanced rcc. cabometyx is indicated for the treatment of patients with hepatocellular carcinoma (hcc) who have been previously treated with sorafenib. cabometyx is indicated for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (dtc) that has progressed following prior vegfr-targeted therapy and who are radioactive iodine-refractory or ineligible. none. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , cabometyx can cause fetal harm when administered to a pregnant woman. there are no available data in pregnant women to inform the drug-associated risk. in animal developmental and reproductive toxicology studies administration of cabozantinib to pregnant rats and rab

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

ipsen pty ltd - cabozantinib (s)-malate, quantity: 50.69 mg (equivalent: cabozantinib, qty 40 mg) - tablet, film coated - excipient ingredients: lactose; microcrystalline cellulose; hypromellose; croscarmellose sodium; iron oxide yellow; hyprolose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; triacetin - renal cell carcinoma (rcc),cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):,- in treatment-na?ve adults with intermediate or poor risk,- in adults following prior treatment with vascular endothelial growth factor targeted therapy.,cabometyx in combination with nivolumab is indicated for the first-line treatment of advanced renal cell carcinoma.,hepatocellular carcinoma (hcc),cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.,differentiated thyroid carcinoma (dtc),cabometyx is indicated as monotherapy for the treatment of adult and paediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid carcinoma (dtc) that has progressed during or after prior vegfr-targeted therapy and who are radioactive iodine (rai) refractory or ineligible.

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

ipsen pty ltd - cabozantinib (s)-malate, quantity: 25.34 mg (equivalent: cabozantinib, qty 20 mg) - tablet, film coated - excipient ingredients: magnesium stearate; triacetin; titanium dioxide; lactose; microcrystalline cellulose; colloidal anhydrous silica; hyprolose; croscarmellose sodium; hypromellose; iron oxide yellow - renal cell carcinoma (rcc),cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):,- in treatment-na?ve adults with intermediate or poor risk,- in adults following prior treatment with vascular endothelial growth factor targeted therapy.,cabometyx in combination with nivolumab is indicated for the first-line treatment of advanced renal cell carcinoma.,hepatocellular carcinoma (hcc),cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.,differentiated thyroid carcinoma (dtc),cabometyx is indicated as monotherapy for the treatment of adult and paediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid carcinoma (dtc) that has progressed during or after prior vegfr-targeted therapy and who are radioactive iodine (rai) refractory or ineligible.

Israel - English - Ministry of Health

medison pharma ltd - cabozantinib as (s) malate - film coated tablets - cabozantinib as (s) malate 20 mg - cabozantinib - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for advanced renal cell carcinoma- as first-line treatment of adult patients with intermediate or poor risk, per imdc criteria.- in adults following prior vascular endothelial growth factor (vegf)-targeted therapy.cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc), in adults with child-pugh class a hepatic impairment who have previously been treated with sorafenib.differentiated thyroid carcinoma (dtc)cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (dtc), refractory or not eligible to radioactive iodine (rai) who have progressed during or after prior systemic therapy.

Israel - English - Ministry of Health

medison pharma ltd - cabozantinib as (s) malate - film coated tablets - cabozantinib as (s) malate 40 mg - cabozantinib - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for advanced renal cell carcinoma- as first-line treatment of adult patients with intermediate or poor risk, per imdc criteria.- in adults following prior vascular endothelial growth factor (vegf)-targeted therapy.cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc), in adults with child-pugh class a hepatic impairment who have previously been treated with sorafenib.differentiated thyroid carcinoma (dtc)cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (dtc), refractory or not eligible to radioactive iodine (rai) who have progressed during or after prior systemic therapy.

Israel - English - Ministry of Health

medison pharma ltd - cabozantinib as (s) malate - film coated tablets - cabozantinib as (s) malate 60 mg - cabozantinib - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for advanced renal cell carcinoma- as first-line treatment of adult patients with intermediate or poor risk, per imdc criteria.- in adults following prior vascular endothelial growth factor (vegf)-targeted therapy.cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc), in adults with child-pugh class a hepatic impairment who have previously been treated with sorafenib.differentiated thyroid carcinoma (dtc)cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (dtc), refractory or not eligible to radioactive iodine (rai) who have progressed during or after prior systemic therapy.

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

ipsen pty ltd - cabozantinib (s)-malate, quantity: 76.03 mg (equivalent: cabozantinib, qty 60 mg) - tablet, film coated - excipient ingredients: titanium dioxide; magnesium stearate; hypromellose; triacetin; colloidal anhydrous silica; iron oxide yellow; hyprolose; lactose; croscarmellose sodium; microcrystalline cellulose - renal cell carcinoma (rcc),cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):,- in treatment-na?ve adults with intermediate or poor risk,- in adults following prior treatment with vascular endothelial growth factor targeted therapy.,cabometyx in combination with nivolumab is indicated for the first-line treatment of advanced renal cell carcinoma.,hepatocellular carcinoma (hcc),cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.,differentiated thyroid carcinoma (dtc),cabometyx is indicated as monotherapy for the treatment of adult and paediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid carcinoma (dtc) that has progressed during or after prior vegfr-targeted therapy and who are radioactive iodine (rai) refractory or ineligible.

Kenya - English - Pharmacy and Poisons Board

beacon medicare limited 9/b/2, toyenbee circular road, - cabozantinib - tablet - cabozantinib 60 mg - cabozantinib

European Union - English - EMA (European Medicines Agency)

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - antineoplastic agents - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (vegf)-targeted therapy.cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.