欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Faslodex
适用类别Human
治疗领域Breast Neoplasms
通用名/非专利名称fulvestrant
活性成分fulvestrant
产品号EMEA/H/C/000540
患者安全信息No
许可状态Authorised
ATC编码L02BA03
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2004/03/09
上市许可开发者/申请人/持有人AstraZeneca AB
人用药物治疗学分组Endocrine therapy;Anti-estrogens
兽用药物治疗学分组
欧盟委员会决定日期2025/05/14
修订号26
治疗适应症Faslodex is indicated as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.
适用物种
兽用药物ATC编码
首次发布日期2018/03/21
最后更新日期2025/05/15
产品说明书https://www.ema.europa.eu/en/documents/product-information/faslodex-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/faslodex
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