法规知识库 · EMA 集中审评
Thiotepa Riemser
thiotepa · EMEA/H/C/005434 · 已授权
获批上市许可
2021-03-26
欧委会决定日
2026-10-06
持有人 / 申请人
Esteve Pharmaceuticals GmbH
终止日期字段
无
从产品到官方文件
文件记录
7
官方索引 7
EPAR / 审评
5
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01AC01
治疗领域：Hematopoietic Stem Cell Transplantation;Neoplasms
药理分类：Antineoplastic agents
修订号：6 · 最新影响 PI 的程序：N/0000378804
适应症（原文）：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
关键日期时间轴
来自 EMA medicines JSON 日期字段；缺失字段不展示，不补推结论。
2026-10-06 · 欧委会决定
2021-03-26 · 获批上市许可
2021-01-28 · CHMP 意见通过
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url；本站不下载或镜像 PDF。
EPAR / 审评资料
- 打开官方文件 ↗
Thiotepa Riemser : EPAR - Procedural steps taken and scientific information after the authorisation
procedural-steps-after · 2026-10-07
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Thiotepa Riemser : EPAR - Procedural steps taken and scientific information after the authorisation (archive)
procedural-steps-after · 2026-08-06
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Thiotepa Riemser : EPAR - Medicine overview
overview · 2021-04-30 · EMA/94265/2021
- 打开官方文件 ↗
Thiotepa Riemser : EPAR - Public assessment report
assessment-report · 2021-04-30 · EMA/129214/2021
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Thiotepa Riemser : EPAR - Risk-management-plan summary
rmp-summary · 2021-04-30
数据来自 EMA 官方 JSON；最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。