欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Afinitor
适用类别Human
治疗领域Carcinoma, Renal Cell;Breast Neoplasms;Pancreatic Neoplasms
通用名/非专利名称everolimus
活性成分everolimus
产品号EMEA/H/C/001038
患者安全信息No
许可状态Authorised
ATC编码L01XE10
是否额外监管No
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2009/08/02
上市许可开发者/申请人/持有人Novartis Europharm Limited
人用药物治疗学分组Antineoplastic agents
兽用药物治疗学分组
欧盟委员会决定日期2025/11/20
修订号33
治疗适应症Hormone-receptor-positive advanced breast cancer Afinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. Neuroendocrine tumours of pancreatic origin Afinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease. Neuroendocrine tumours of gastrointestinal or lung origin Afinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease. Renal-cell carcinoma Afinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.
适用物种
兽用药物ATC编码
首次发布日期2018/05/08
最后更新日期2025/11/20
产品说明书https://www.ema.europa.eu/en/documents/product-information/afinitor-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/afinitor
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