法规知识库 · EMA 集中审评
Instanyl
Fentanyl citrate · EMEA/H/C/000959 · 已授权
获批上市许可
2009-07-20
欧委会决定日
2026-10-22
持有人 / 申请人
Istituto Gentili S.r.l.
终止日期字段
无
从产品到官方文件
文件记录
14
官方索引 14
EPAR / 审评
12
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：N02AB03
治疗领域：Pain;Cancer
药理分类：Analgesics
修订号：42 · 最新影响 PI 的程序：N/0000383164
适应症（原文）：Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
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。
2026-10-22 · 欧委会决定
2009-07-20 · 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
- 打开官方文件 ↗
Instanyl : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-22
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Instanyl : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-05-21
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Instanyl-H-C-PSUSA-00001369-202304 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2024-04-05 · EMA/57780/2024
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Instanyl : EPAR - Risk management plan
rmp-summary · 2024-04-05
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Instanyl-H-C-PSUSA-00001369-202004 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-04-14 · EMA/209713/2021
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Instanyl-H-C-PSUSA-00001369-201704 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-07-23 · EMA/378606/2018
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Instanyl : EPAR - Medicine overview
overview · 2019-07-23 · EMA/163439/2019
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Instanyl-H-C-PSUSA/00001369/201704 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-06-12 · EMA/378606/2018
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Instanyl-H-C-PSUSA-00001369-201404 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-08-20 · EMA/CHMP/282039/2015
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Instanyl-H-C-PSUSA-00001369-201304 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-04-14 · EMA/136275/2014
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Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
conditions-member-states · 2011-07-11
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Instanyl : EPAR - Public assessment report
assessment-report · 2009-07-30
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。