欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Adcetris
适用类别Human
治疗领域Lymphoma, Non-Hodgkin;Hodgkin Disease
通用名/非专利名称brentuximab vedotin
活性成分Brentuximab vedotin
产品号EMEA/H/C/002455
患者安全信息No
许可状态Authorised
ATC编码L01FX05
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2012/10/25
上市许可开发者/申请人/持有人Takeda Pharma A/S
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2012/07/19
欧盟委员会决定日期2025/06/02
修订号37
治疗适应症Hodgkin lymphomaAdcetris is indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD).Adcetris is indicated for adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD).Adcetris is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT).Adcetris is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):- following ASCT, or- following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.Systemic anaplastic large cell lymphomaAdcetris in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL). Adcetris is indicated for the treatment of adult patients with relapsed or refractory sALCL.Cutaneous T-cell lymphomaAdcetris is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy.
适用物种
兽用药物ATC编码
首次发布日期2018/07/25
最后更新日期2025/12/04
产品说明书https://www.ema.europa.eu/en/documents/product-information/adcetris-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/adcetris
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