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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。

  1. 2025-05-22 · 欧委会决定

  2. 2020-11-16 · 获批上市许可

  3. 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 4产品信息 2其他 0

EPAR / 审评资料

产品信息

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。