欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Thiotepa Riemser
适用类别Human
治疗领域Hematopoietic Stem Cell Transplantation;Neoplasms
通用名/非专利名称thiotepa
活性成分thiotepa
产品号EMEA/H/C/005434
患者安全信息No
许可状态Authorised
ATC编码L01AC01
是否额外监管No
是否仿制药或hybrid药物Yes
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2021/03/26
上市许可开发者/申请人/持有人Esteve Pharmaceuticals GmbH
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2021/01/28
欧盟委员会决定日期2023/10/18
修订号4
治疗适应症Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products: with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients; when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients. Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products: with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients; when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients
适用物种
兽用药物ATC编码
首次发布日期2021/04/30
最后更新日期2023/10/23
产品说明书https://www.ema.europa.eu/en/documents/product-information/thiotepa-riemser-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/thiotepa-riemser
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