Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
sunitinib
Pfizer Limited
L01EX01
sunitinib
Antineoplastic agents
Gastrointestinal Stromal Tumors; Carcinoma, Renal Cell; Neuroendocrine Tumors
Gastrointestinal stromal tumour (GIST)Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib mesilate treatment due to resistance or intolerance.Metastatic renal cell carcinoma (MRCC)Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.Pancreatic neuroendocrine tumours (pNET)Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults.Experience with Sutent as first-line treatment is limited (see section 5.1).
Revision: 39
Authorised
2006-07-19
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 12.5 mg hard capsules Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib. 25 mg hard capsules Each capsule contains sunitinib malate, equivalent to 25 mg of sunitinib. 37.5 mg hard capsules Each capsule contains sunitinib malate, equivalent to 37.5 mg of sunitinib. 50 mg hard capsules Each capsule contains sunitinib malate, equivalent to 50 mg of sunitinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Sutent 12.5 mg hard capsules Gelatin capsules with orange cap and orange body, printed with white ink “Pfizer” on the cap, “STN 12.5 mg” on the body, and containing yellow to orange granules. Sutent 25 mg hard capsules Gelatin capsules with caramel cap and orange body, printed with white ink “Pfizer” on the cap, “STN 25 mg” on the body, and containing yellow to orange granules. Sutent 37.5 mg hard capsules Gelatin capsules with yellow cap and yellow body, printed with black ink “Pfizer” on the cap, “STN 37.5 mg” on the body, and containing yellow to orange granules. Sutent 50 mg hard capsules Gelatin capsule with caramel cap and caramel body, printed with white ink “Pfizer” on the cap, “STN 50 mg” on the body, and containing yellow to orange granules. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Gastrointestinal stromal tumour (GIST) Sutent 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) Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. 3 Pancreatic neuroendocrine tumours (pNET) Sutent is indicated for the treatment of unresectable or metastatic, well Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 12.5 mg hard capsules Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib. 25 mg hard capsules Each capsule contains sunitinib malate, equivalent to 25 mg of sunitinib. 37.5 mg hard capsules Each capsule contains sunitinib malate, equivalent to 37.5 mg of sunitinib. 50 mg hard capsules Each capsule contains sunitinib malate, equivalent to 50 mg of sunitinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Sutent 12.5 mg hard capsules Gelatin capsules with orange cap and orange body, printed with white ink “Pfizer” on the cap, “STN 12.5 mg” on the body, and containing yellow to orange granules. Sutent 25 mg hard capsules Gelatin capsules with caramel cap and orange body, printed with white ink “Pfizer” on the cap, “STN 25 mg” on the body, and containing yellow to orange granules. Sutent 37.5 mg hard capsules Gelatin capsules with yellow cap and yellow body, printed with black ink “Pfizer” on the cap, “STN 37.5 mg” on the body, and containing yellow to orange granules. Sutent 50 mg hard capsules Gelatin capsule with caramel cap and caramel body, printed with white ink “Pfizer” on the cap, “STN 50 mg” on the body, and containing yellow to orange granules. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Gastrointestinal stromal tumour (GIST) Sutent 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) Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. 3 Pancreatic neuroendocrine tumours (pNET) Sutent is indicated for the treatment of unresectable or metastatic, well Lestu allt skjalið