Australija - engleski - Department of Health (Therapeutic Goods Administration)

bristol-myers squibb australia pty ltd - ipilimumab, quantity: 53.5 mg - injection, concentrated - excipient ingredients: trometamol hydrochloride; sodium chloride; mannitol; pentetic acid; polysorbate 80; sodium hydroxide; hydrochloric acid; water for injections - melanoma,yervoy, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma.,yervoy, in combination with nivolumab, is indicated for the treatment of patients with unresectable or metastatic melanoma. the approval of this indication is based on a pre-specified comparison to ipilimumab monotherapy. all analyses comparing nivolumab monotherapy with the nivolumab/ipilimumab combination are descriptive.,renal cell carcinoma (rcc),yervoy, in combination with nivolumab, is indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.,non-small cell lung cancer (nsclc),yervoy, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (nsclc) with no egfr or alk genomic tumour aberrations.,malignant pleural mesothelioma (mpm),yervoy, in combination with nivolumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.,oesophageal squamous cell carcinoma (oscc),yervoy in combination with nivolumab is indicated for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression greater than or equal to 1% as determined by a validated test.

Europska Unija - engleski - 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.

Australija - engleski - 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.

Australija - engleski - 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.

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - ipilimumab 5 mg/ml;   - concentrate for injection - 200 mg/40 ml - active: ipilimumab 5 mg/ml   excipient: hydrochloric acid mannitol nitrogen pentetic acid polysorbate 80 sodium chloride sodium hydroxide trometamol hydrochloride water for injection - yervoy, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma in adults, 18 years of age or older. yervoy, in combination with opdivo (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic disease melanoma.

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - ipilimumab 5 mg/ml;   - concentrate for injection - 50 mg/10 ml - active: ipilimumab 5 mg/ml   excipient: hydrochloric acid mannitol nitrogen pentetic acid polysorbate 80 sodium chloride sodium hydroxide trometamol hydrochloride water for injection - yervoy, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma in adults, 18 years of age or older. yervoy, in combination with opdivo (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic disease melanoma.

Velika Britanija - engleski - MHRA (Medicines & Healthcare Products Regulatory Agency)

bristol-myers squibb pharmaceuticals ltd - ipilimumab - solution for infusion - 5mg/1ml

Velika Britanija - engleski - MHRA (Medicines & Healthcare Products Regulatory Agency)

bristol-myers squibb pharmaceuticals ltd - ipilimumab - solution for infusion - 5mg/1ml

Malezija - engleski - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

zuellig pharma sdn bhd - cabozantinib (s)-malate -

Malezija - engleski - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

zuellig pharma sdn bhd - cabozantinib (s)-malate -