Malta - English - Medicines Authority

pharmacare premium limited hhf 003 halfar industrial estate birzebbugia bbg 3000, malta - hard capsule - sunitinib 50 mg - antineoplastic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

bluefish pharmaceuticals ab - sunitinib - capsule, hard - sunitinib

Ireland - English - HPRA (Health Products Regulatory Authority)

bluefish pharmaceuticals ab - sunitinib - capsule, hard - sunitinib

Ireland - English - HPRA (Health Products Regulatory Authority)

bluefish pharmaceuticals ab - sunitinib - capsule, hard - sunitinib

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

arrotex pharmaceuticals pty ltd - sunitinib malate, quantity: 66.825 mg (equivalent: sunitinib, qty mg) - capsule, hard - excipient ingredients: gelatin; mannitol; magnesium stearate; titanium dioxide; purified water; croscarmellose sodium; povidone; iron oxide black; iron oxide yellow; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia; potassium hydroxide - arx-sunitinib 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)

arrotex pharmaceuticals pty ltd - sunitinib malate, quantity: 50.119 mg (equivalent: sunitinib, qty mg) - capsule, hard - excipient ingredients: gelatin; mannitol; magnesium stearate; titanium dioxide; purified water; croscarmellose sodium; povidone; iron oxide yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - arx-sunitinib 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)

arrotex pharmaceuticals pty ltd - sunitinib malate, quantity: 33.413 mg (equivalent: sunitinib, qty 25 mg) - capsule, hard - excipient ingredients: gelatin; mannitol; magnesium stearate; iron oxide red; titanium dioxide; purified water; croscarmellose sodium; povidone; iron oxide yellow; iron oxide black; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia; potassium hydroxide - arx-sunitinib 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)

arrotex pharmaceuticals pty ltd - sunitinib malate, quantity: 16.706 mg (equivalent: sunitinib, qty 12.5 mg) - capsule, hard - excipient ingredients: gelatin; mannitol; magnesium stearate; iron oxide red; titanium dioxide; purified water; croscarmellose sodium; povidone; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia; potassium hydroxide - arx-sunitinib 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).

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

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - sunitinib 12,5 mg - capsule, hard - 12,5 mg - sunitinib 12.5 mg - sunitinib