欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Zirabev
适用类别Human
治疗领域Colorectal Neoplasms;Breast Neoplasms;Carcinoma, Non-Small-Cell Lung;Carcinoma, Renal Cell;Uterine Cervical Neoplasms
通用名/非专利名称bevacizumab
活性成分bevacizumab
产品号EMEA/H/C/004697
患者安全信息No
许可状态Authorised
ATC编码L01XC07
是否额外监管Yes
是否仿制药或hybrid药物No
是否生物类似药Yes
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2019/02/14
上市许可开发者/申请人/持有人Pfizer Europe MA EEIG
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2018/12/13
欧盟委员会决定日期2025/09/11
修订号17
治疗适应症Zirabev in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Zirabev in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status. Zirabev, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Zirabev in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Zirabev, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.
适用物种
兽用药物ATC编码
首次发布日期2018/12/11
最后更新日期2025/09/17
产品说明书https://www.ema.europa.eu/en/documents/product-information/zirabev-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/zirabev
©2006-2025 DrugFuture->European Medicines Agency Authorisation of Medicines DataBase