欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Bortezomib Sun
适用类别Human
治疗领域Multiple Myeloma
通用名/非专利名称bortezomib
活性成分bortezomib
产品号EMEA/H/C/004076
患者安全信息No
许可状态Authorised
ATC编码L01XG01
是否额外监管Nei
是否仿制药或hybrid药物
是否生物类似药Nei
是否附条件批准Nei
是否特殊情形Nei
是否加速审评Nei
是否罕用药Nei
上市许可日期2016/07/22
上市许可开发者/申请人/持有人SUN Pharmaceutical Industries (Europe) B.V.
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2016/03/26
欧盟委员会决定日期2025/10/10
修订号15
治疗适应症Bortezomib SUN as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Bortezomib SUN in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib SUN in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib SUN in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
适用物种
兽用药物ATC编码
首次发布日期2017/09/07
最后更新日期2025/10/14
产品说明书https://www.ema.europa.eu/en/documents/product-information/bortezomib-sun-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/bortezomib-sun
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