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

teva pharmaceuticals usa, 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 summary based 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 t

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

pfizer laboratories div pfizer inc - sunitinib malate (unii: lvx8n1ut73) (sunitinib - unii:v99t50803m) - sunitinib 12.5 mg - sutent is indicated for the treatment of adult patients with gastrointestinal stromal tumor (gist) after disease progression on or intolerance to imatinib mesylate. sutent is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc). sutent is indicated for the adjuvant treatment of adult patients at high risk of recurrent rcc following nephrectomy. sutent is indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pnet) in adult patients with unresectable locally advanced or metastatic disease. none. risk summary based on animal reproduction studies and its mechanism of action, sutent 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 rabbits throughout organogenesis resulted in teratogenicity (embryolet

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - sunitinib 12.5mg - capsule - 12.5 mg - active: sunitinib 12.5mg excipient: croscarmellose sodium gelatin printing ink, white iron oxide red magnesium stearate mannitol microcrystalline cellulose povidone titanium dioxide - treatment of advanced renal cell carcinoma

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - sunitinib 25mg - capsule - 25 mg - active: sunitinib 25mg excipient: croscarmellose sodium gelatin printing ink, white iron oxide black iron oxide red iron oxide yellow magnesium stearate mannitol microcrystalline cellulose povidone titanium dioxide - treatment of advanced renal cell carcinoma

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - sunitinib 37.5mg - capsule - 37.5 mg - active: sunitinib 37.5mg excipient: croscarmellose sodium gelatin printing ink, black iron oxide yellow magnesium stearate mannitol microcrystalline cellulose povidone titanium dioxide - treatment of advanced renal cell carcinoma

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - sunitinib 50mg - capsule - 50 mg - active: sunitinib 50mg excipient: croscarmellose sodium gelatin printing ink, white iron oxide black iron oxide red iron oxide yellow magnesium stearate mannitol microcrystalline cellulose povidone titanium dioxide - treatment of advanced renal cell carcinoma

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - sunitinib malate 16.7mg equivalent to sunitinib 12.5mg;   - capsule - 12.5 mg - active: sunitinib malate 16.7mg equivalent to sunitinib 12.5mg   excipient: croscarmellose sodium gelatin ink iron oxide red magnesium stearate mannitol povidone sodium laurilsulfate titanium dioxide - treatment of advanced renal cell carcinoma

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - sunitinib malate 33.4mg equivalent to sunitinib 25mg;   - capsule - 25 mg - active: sunitinib malate 33.4mg equivalent to sunitinib 25mg   excipient: croscarmellose sodium gelatin ink iron oxide black iron oxide red iron oxide yellow magnesium stearate mannitol povidone sodium laurilsulfate titanium dioxide - treatment of advanced renal cell carcinoma

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - sunitinib malate 50.1mg equivalent to sunitinib 37.5mg;   - capsule - 37.5 mg - active: sunitinib malate 50.1mg equivalent to sunitinib 37.5mg   excipient: croscarmellose sodium gelatin ink iron oxide yellow magnesium stearate mannitol povidone sodium laurilsulfate titanium dioxide - treatment of advanced renal cell carcinoma

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - sunitinib malate 66.8mg equivalent to sunitinib 50mg;   - capsule - 50 mg - active: sunitinib malate 66.8mg equivalent to sunitinib 50mg   excipient: croscarmellose sodium gelatin ink iron oxide black iron oxide red iron oxide yellow magnesium stearate mannitol povidone sodium laurilsulfate titanium dioxide - treatment of advanced renal cell carcinoma