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

northstar rxllc - 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 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 pregna

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

sandoz pty ltd - sunitinib, quantity: 50 mg - capsule - excipient ingredients: magnesium stearate; microcrystalline cellulose; gelatin; povidone; iron oxide red; mannitol; titanium dioxide; croscarmellose sodium; iron oxide black; iron oxide yellow; propylene glycol; butan-1-ol; isopropyl alcohol; ethanol; shellac; strong ammonia solution; sulfuric acid - ? 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)

sandoz pty ltd - sunitinib, quantity: 37.5 mg - capsule - excipient ingredients: povidone; croscarmellose sodium; titanium dioxide; magnesium stearate; microcrystalline cellulose; gelatin; mannitol; iron oxide yellow; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid - ? 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)

sandoz pty ltd - sunitinib, quantity: 12.5 mg - capsule - excipient ingredients: titanium dioxide; povidone; microcrystalline cellulose; iron oxide red; gelatin; mannitol; magnesium stearate; croscarmellose sodium; propylene glycol; butan-1-ol; isopropyl alcohol; ethanol; shellac; strong ammonia solution; sulfuric acid - ? 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)

sandoz pty ltd - sunitinib, quantity: 25 mg - capsule - excipient ingredients: magnesium stearate; gelatin; croscarmellose sodium; mannitol; povidone; microcrystalline cellulose; iron oxide red; titanium dioxide; iron oxide yellow; iron oxide black; propylene glycol; butan-1-ol; isopropyl alcohol; ethanol; shellac; strong ammonia solution; sulfuric acid - ? 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)

sandoz pty ltd - sunitinib, quantity: 25 mg - capsule - excipient ingredients: gelatin; croscarmellose sodium; magnesium stearate; microcrystalline cellulose; povidone; mannitol; titanium dioxide; iron oxide red; iron oxide yellow; iron oxide black; propylene glycol; butan-1-ol; isopropyl alcohol; ethanol; shellac; strong ammonia solution; sulfuric acid - ? 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)

sandoz pty ltd - sunitinib, quantity: 37.5 mg - capsule - excipient ingredients: povidone; gelatin; microcrystalline cellulose; magnesium stearate; mannitol; titanium dioxide; croscarmellose sodium; iron oxide yellow; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid - ? 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)

sandoz pty ltd - sunitinib, quantity: 50 mg - capsule - excipient ingredients: gelatin; titanium dioxide; croscarmellose sodium; magnesium stearate; microcrystalline cellulose; iron oxide red; povidone; mannitol; propylene glycol; butan-1-ol; isopropyl alcohol; ethanol; shellac; strong ammonia solution; sulfuric acid - ? 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)

sandoz pty ltd - sunitinib, quantity: 12.5 mg - capsule - excipient ingredients: magnesium stearate; mannitol; gelatin; iron oxide red; microcrystalline cellulose; povidone; croscarmellose sodium; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; ethanol; shellac; strong ammonia solution; sulfuric acid - ? 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).

Canada - English - Health Canada

taro pharmaceuticals inc - sunitinib (sunitinib malate) - capsule - 37.5mg - sunitinib (sunitinib malate) 37.5mg