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

pfizer australia pty ltd - sunitinib malate, quantity: 16.7 mg (equivalent: sunitinib, qty 12.5 mg) - capsule - excipient ingredients: sodium hydroxide; propylene glycol; shellac; sodium lauryl sulfate; iron oxide red; mannitol; magnesium stearate; titanium dioxide; povidone; gelatin; croscarmellose sodium - sutent is indicated for: ? treatment of advanced renal cell carcinoma (rcc) ? treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance ? treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net).

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

pfizer australia pty ltd - sunitinib malate, quantity: 16.7 mg (equivalent: sunitinib, qty 12.5 mg) - capsule - excipient ingredients: gelatin; sodium hydroxide; sodium lauryl sulfate; iron oxide red; magnesium stearate; shellac; povidone; titanium dioxide; propylene glycol; mannitol; croscarmellose sodium - sutent is indicated for: ? treatment of advanced renal cell carcinoma (rcc) ? treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance ? treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net).

Malta - English - Medicines Authority

medichem, s.a. fructuós gelabert 6-8, 08970, sant joan despí, (barcellona), spain - sunitinib - hard capsule - sunitinib 12.5 mg - antineoplastic agents

Malta - English - Medicines Authority

medichem, s.a. fructuós gelabert 6-8, 08970, sant joan despí, (barcellona), spain - sunitinib - hard capsule - sunitinib 25 mg - antineoplastic agents

Malta - English - Medicines Authority

medichem, s.a. fructuós gelabert 6-8, 08970, sant joan despí, (barcellona), spain - sunitinib - hard capsule - sunitinib 37.5 mg - antineoplastic agents

Malta - English - Medicines Authority

medichem, s.a. fructuós gelabert 6-8, 08970, sant joan despí, (barcellona), spain - sunitinib - hard capsule - sunitinib 50 mg - antineoplastic agents

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

dr.reddys laboratories inc - sunitinib malate (unii: lvx8n1ut73) (sunitinib - unii:v99t50803m) - sunitinib malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (gist) after disease progression on or intolerance to imatinib mesylate. sunitinib malate capsules are indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc). sunitinib malate capsules are indicated for the adjuvant treatment of adult patients at high risk of recurrent rcc following nephrectomy. sunitinib malate capsules are indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pnet) in adult patients with unresectable locally advanced or metastatic disease. none. risk summarybased on animal reproduction studies and its mechanism of action, sunitinib malate 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 a drug-associated risk. in animal developmental and reproductive toxicology studies, oral administration of sunitinib to

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastic agents - gastrointestinal stromal tumour (gist)sunitinib accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib treatment due to resistance or intolerance.metastatic renal cell carcinoma (mrcc)sunitinib accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults.pancreatic neuroendocrine tumours (pnet)sunitinib accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pnet) with disease progression in adults.

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

mylan pharmaceuticals inc. - sunitinib malate (unii: lvx8n1ut73) (sunitinib - unii:v99t50803m) - sunitinib malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (gist) after disease progression on or intolerance to imatinib mesylate. sunitinib malate capsules are indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc). sunitinib malate capsules are indicated for the adjuvant treatment of adult patients at high risk of recurrent rcc following nephrectomy. sunitinib malate capsules are indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pnet) in adult patients with unresectable locally advanced or metastatic disease. none. based on animal reproduction studies and its mechanism of action, sunitinib 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 a drug-associated risk. in animal developmental and reproductive toxicology studies, oral administration of sunitinib to pregnant rats and

Israel - English - Ministry of Health

teva israel ltd - sunitinib as base - capsules - sunitinib as base 12.5 mg - sunitinib - sunitinib teva is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate. sunitinib teva is indicated for the treatment of advanced renal cell carcinoma. treatment of unresectable or metastatic, well differentiated pancreatic neuroendocrine tumours (pnet) with disease progression.