欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Kisqali
适用类别Human
治疗领域Breast Neoplasms
通用名/非专利名称ribociclib
活性成分ribociclib succinate
产品号EMEA/H/C/004213
患者安全信息No
许可状态Authorised
ATC编码L01EF02
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2017/08/22
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
审评意见日期2017/06/22
欧盟委员会决定日期2025/10/20
修订号23
治疗适应症Early breast cancerKisqali in combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence (see section 5.1 for selection criteria).In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.Advanced or metastatic breast cancerKisqali is indicated for the treatment of women with HR-positive, HER2-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.
适用物种
兽用药物ATC编码
首次发布日期2017/08/22
最后更新日期2025/11/12
产品说明书https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/kisqali
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