法规知识库 · EMA 集中审评
Pomalidomide Krka
Pomalidomide · EMEA/H/C/006314 · 已授权
获批上市许可
2024-07-24
欧委会决定日
2025-07-10
持有人 / 申请人
KRKA tovarna zdravil d.d. Novo mesto
终止日期字段
无
从产品到官方文件
文件记录
8
官方索引 8
EPAR / 审评
6
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AX06
治疗领域：Multiple Myeloma
药理分类：Immunosuppressants
修订号：3 · 最新影响 PI 的程序：VR/0000267863
适应症（原文）：Pomalidomide Krka in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalidomide Krka in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
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。
2025-07-10 · 欧委会决定
2024-07-24 · 获批上市许可
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
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Pomalidomide Krka - EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-09-03
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Pomalidomide Krka : EPAR - Risk management plan
rmp · 2026-09-03
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Pomalidomide Krka - EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-03-19
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Pomalidomide Krka : EPAR - Medicine overview
overview · 2024-09-24 · EMA/281832/2024
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Pomalidomide Krka : EPAR - Conditions imposed on member states for safe and effective use - Annex related to Art. 127a
conditions-member-states · 2024-08-01
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Pomalidomide Krka : EPAR - Public assessment report
assessment-report · 2024-08-01 · EMA/341648/2024
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。