法规知识库 · EMA 集中审评
Phelinun
melphalan hydrochloride · EMEA/H/C/005173 · 已授权
获批上市许可
2020-11-16
欧委会决定日
2025-05-22
持有人 / 申请人
未知
终止日期字段
无
从产品到官方文件
文件记录
6
官方索引 6
EPAR / 审评
4
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:L01AA03
治疗领域:Multiple Myeloma;Hodgkin Disease;Lymphoma, Non-Hodgkin;Precursor Cell Lymphoblastic Leukemia-Lymphoma;Leukemia, Myeloid, Acute;Neuroblastoma;Ovarian Neoplasms;Hematopoietic Stem Cell Transplantation
药理分类:Antineoplastic agents
修订号:3 · 最新影响 PI 的程序:R/0005
适应症(原文):High-dose of Phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of: multiple myeloma, malignant lymphoma (Hodgkin, non-Hodgkin lymphoma), acute lymphoblastic and myeloblastic leukemia, childhood neuroblastoma, ovarian cancer, mammary adenocarcinoma. Phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (RIC) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-HSCT) in malignant haematological diseases in adults. Phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as: Myeloablative conditioning (MAC) treatment in case of malignant haematological diseases RIC treatment in case of non-malignant haematological diseases.
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。
2025-05-22 · 欧委会决定
2020-11-16 · 获批上市许可
2020-09-17 · 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 ↗
Phelinun : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-06-18
- 打开官方文件 ↗
Phelinun : EPAR - Medicine overview
overview · 2020-11-25
- 打开官方文件 ↗
Phelinun : EPAR - Public assessment report
assessment-report · 2020-11-25 · EMA/CHMP/624882/2020
- 打开官方文件 ↗
Phelinun : EPAR - Risk-assessment-report summary
rmp-summary · 2020-11-25
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。