法规知识库 · EMA 集中审评
Rapamune
sirolimus · EMEA/H/C/000273 · 已授权
获批上市许可
2001-03-13
欧委会决定日
2026-06-03
持有人 / 申请人
Pfizer Europe MA EEIG
终止日期字段
无
从产品到官方文件
文件记录
13
官方索引 13
EPAR / 审评
10
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AH01
治疗领域：Graft Rejection;Kidney Transplantation
药理分类：Immunosuppressants
修订号：51 · 最新影响 PI 的程序：VR/0000334549
适应症（原文）：Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued. Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function.
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。
2026-06-03 · 欧委会决定
2001-03-13 · 获批上市许可
2000-11-16 · 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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Rapamune : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-06-04
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Rapamune : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-02-04
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Rapamune : EPAR - Risk-management-plan summary
rmp-summary · 2022-06-08
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Rapamune-H-C-PSUSA-00002710-202009 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-07-28 · EMA/CHMP/425641/2021
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Rapamune : EPAR - Medicine overview
overview · 2018-09-13
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Rapamune-H-C-273-II-0164 : EPAR - Assessment Report - Variation
variation-report · 2018-08-08 · EMA/493416/2018
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Rapamune : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2009-06-16
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Rapamune-H-C-273-X-0021 : EPAR - Scientific Discussion - Extension
scientific-discussion-variation · 2006-08-08
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Rapamune : EPAR - Scientific Discussion
scientific-discussion · 2006-08-08
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Rapamune : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2006-08-08
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。