法规知识库 · EMA 集中审评
Hycamtin
topotecan · EMEA/H/C/000123 · 已授权
获批上市许可
1996-11-12
欧委会决定日
2026-01-20
持有人 / 申请人
Sandoz Pharmaceuticals d.d.
终止日期字段
无
从产品到官方文件
文件记录
12
官方索引 12
EPAR / 审评
9
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L01CE01
治疗领域：Ovarian Neoplasms;Uterine Cervical Neoplasms;Small Cell Lung Carcinoma
药理分类：Antineoplastic agents
修订号：42 · 最新影响 PI 的程序：N/0000320277
适应症（原文）：Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy. Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.
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。
2026-01-20 · 欧委会决定
1996-11-12 · 获批上市许可
1996-07-17 · 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
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Hycamtin : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-01-20
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Hycamtin : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-01-20
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Hycamtin : EPAR - Risk-management-plan summary
rmp-summary · 2021-11-24
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Hycamtin : EPAR - Summary for the public
overview · 2015-06-26
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Hycamtin-H-C-123-II-0038 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2006-12-12
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Hycamtin : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2006-02-20
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Hycamtin : EPAR - Scientific Discussion
scientific-discussion · 2006-02-20
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Hycamtin : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-02-20
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Hycamtin-H-C-123-II-0034 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2006-02-20
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。