EPARs - Sutent/Sunitnib

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EPARs for authorised medicinal products for human use - Sutent

Active Substance
sunitinib malate
International Nonproprietary Name or Common Name
sunitinib
Pharmaco-therapeutic Group
Antineoplastic agents - Protein kinase inhibitors
ATC Code
L01XE04

Therapeutic Indication:
Gastrointestinal Stromal Tumour (GIST)
Sutent is indicated for the treatment of unresectable and/or metastatic malignantgastrointestinal stromal tumour (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance.

Metastatic Renal Cell Carcinoma (MRCC)
Sutent is indicated for the treatment of advanced and/ormetastatic renal cell carcinoma (MRCC).

Date of issue of Marketing Authorisation valid throughout the European Union
19 July 2006

Orphan medicinal product designation date:
This product is no longer an orphan. It was originally an orphan designated on 10 March 2005. Upon request by the MAH, Suten has now been removed from the Community Register of Orphan Medicinal products.