法规知识库 · EMA 集中审评
Iclusig
ponatinib · EMEA/H/C/002695 · 已授权
获批上市许可
2013-07-01
欧委会决定日
2026-07-15
持有人 / 申请人
Incyte Biosciences Distribution B.V.
终止日期字段
无
从产品到官方文件
文件记录
18
官方索引 18
EPAR / 审评
15
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L01EA05
治疗领域：Leukemia, Myeloid;Leukemia, Lymphoid
药理分类：Antineoplastic agents;Protein kinase inhibitors
修订号：30 · 最新影响 PI 的程序：X/0000296489
适应症（原文）：Iclusig is indicated as monotherapy in adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Iclusig is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL (see section 5.1). Iclusig is indicated as monotherapy in paediatric patients 6 years of age or older with chronic phase chronic myeloid leukaemia (CP-CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. See sections 4.2 for the assessment of cardiovascular status prior to start of therapy and 4.4 for situations where an alternative treatment may be considered.
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。
2026-07-15 · 欧委会决定
2013-07-01 · 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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Iclusig-X-0000296489 : EPAR - Assessment Report - Extension
variation-report · 2026-07-31 · EMADOC-1700519818-3228538
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Iclusig : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan
pip-compliance · 2026-07-31 · EMADOC-1700519818-3098633
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Iclusig : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-07-31
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Iclusig : EPAR - Risk management plan
rmp · 2026-07-31
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Iclusig : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-07-31
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Iclusig : EPAR - Medicine overview
overview · 2026-07-30 · EMADOC-1829012207-42319
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Iclusig-VR-0000263550 : EPAR - Assessment report - Variation
variation-report · 2026-03-25 · EMADOC-1700519818-2559402
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Iclusig-H-C-PSUSA-00010128-201712 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-10-10 · EMA/565256/2018
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Iclusig-H-C-PSUSA-00010128-201612 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-09-29 · EMA/637397/2017
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Iclusig-H-C-PSUSA-00010128-201506 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2016-05-02 · EMA/320284/2016
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Iclusig-H-C-2695-X-0023 : EPAR - Assessment Report - Variation
variation-report · 2016-01-11 · EMA/671413/2015
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Iclusig : EPAR - Scientific Conclusion
scientific-conclusion · 2015-02-23
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Iclusig-H-C-2695-A20-0003 : EPAR - Public assessment report - Article 20
variation-report · 2015-02-23 · EMA/667786/2014
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Iclusig-H-C-2695-PSUV-0009: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-11-03 · EMA/669630/2014
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Iclusig : EPAR - Public assessment report
assessment-report · 2013-07-11 · EMA/CHMP/220290/2013
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。