法规知识库 · EMA 集中审评
Xelevia
sitagliptin · EMEA/H/C/000762 · 已授权
获批上市许可
2007-03-21
欧委会决定日
2025-11-24
持有人 / 申请人
Merck Sharp & Dohme B.V.
终止日期字段
无
从产品到官方文件
文件记录
19
官方索引 19
EPAR / 审评
16
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：A10BH01
治疗领域：Diabetes Mellitus, Type 2
药理分类：Drugs used in diabetes
修订号：42 · 最新影响 PI 的程序：N/0000314048
适应症（原文）：For adult patients with type-2 diabetes mellitus, Xelevia is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance; a peroxisome proliferator-activated receptor gamma (PPAR?) agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control; as triple oral therapy in combination with: a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control; a PPAR? agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Xelevia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
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。
2025-11-24 · 欧委会决定
2023-11-14 · CHMP 意见通过
2007-03-21 · 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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Xelevia : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-12-01
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Xelevia : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-12-01
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Xelevia-PAM-0000244508 : EPAR - Assessment report
variation-report · 2025-06-27 · EMADOC-1700519818-1838618
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Xelevia : EPAR - Risk management plan summary
rmp-summary · 2022-06-30
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Xelevia : EPAR - Paediatric investigation plan compliance statement
pip-compliance · 2021-02-24 · EMEA/H/C/000762/IB/0073
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Xelevia : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan (IB-73)
pip-compliance · 2020-11-19 · EMEA/H/C/000762/IB/0073
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Xelevia-H-C-PSUSA-00002711-201708 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-06-22 · EMA/423578/2018
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Xelevia-H-C-PSUSA-00002711-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-07-13 · EMA/304624/2015
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Xelevia-H-C-762-P46-0029 : EPAR - Assessment Report
variation-report · 2013-03-27 · EMA/191361/2013
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Xelevia : EPAR - Summary for the public
overview · 2012-09-21
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Xelevia-H-C-762-II-0012 : EPAR - Assessment Report - Variation
variation-report · 2009-12-08 · EMA/767819/2009
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Xelevia-H-C-762-II-0009 : EPAR - Assessment Report - Variation
variation-report · 2009-10-09
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Xelevia-H-C-762-II-0007 : EPAR - Assessment Report - Variation
variation-report · 2009-07-06
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Xelevia-H-C-762-II-0002 : EPAR - Assessment Report - Variation
variation-report · 2008-05-29
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Xelevia : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2007-03-26
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Xelevia : EPAR - Scientific Discussion
scientific-discussion · 2007-03-26
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。