欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Kadcyla
适用类别Human
治疗领域Breast Neoplasms
通用名/非专利名称trastuzumab emtansine
活性成分trastuzumab emtansine
产品号EMEA/H/C/002389
患者安全信息No
许可状态Authorised
ATC编码L01FD03
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2013/11/15
上市许可开发者/申请人/持有人Roche Registration GmbH
人用药物治疗学分组Antineoplastic agents
兽用药物治疗学分组
审评意见日期2013/09/19
欧盟委员会决定日期2025/02/20
修订号16
治疗适应症Early Breast Cancer (EBC) Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy. Metastatic Breast Cancer (MBC) Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: Received prior therapy for locally advanced or metastatic disease, or Developed disease recurrence during or within six months of completing adjuvant therapy.
适用物种
兽用药物ATC编码
首次发布日期2013/12/19
最后更新日期2025/03/26
产品说明书https://www.ema.europa.eu/en/documents/product-information/kadcyla-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/kadcyla
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