法规知识库 · EMA 集中审评
Tesavel
sitagliptin · EMEA/H/C/000910 · 已授权
获批上市许可
2008-01-10
欧委会决定日
2025-11-28
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
15
官方索引 15
EPAR / 审评
13
assessment / overview 等
产品信息
2
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：29 · 最新影响 PI 的程序：N/0000314584
适应症（原文）：For patients with type-2 diabetes mellitus, Tesavel 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 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 agents do not provide adequate glycaemic control; a peroxisome-proliferator-activated-receptor-gamma (PPAR?) agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control. Tesavel is also indicated as add on to insulin (with or without metformin) when diet and exercise plus stable dosage 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。
2025-11-28 · 欧委会决定
2008-01-10 · 获批上市许可
2007-11-15 · 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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Tesavel : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-12-01
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Tesavel : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-12-01
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Tesavel-PAM-0000244510 : EPAR - Assessment report
variation-report · 2025-06-27 · EMADOC-1700519818-1838618
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Tesavel : EPAR - Risk management plan summary
rmp-summary · 2022-06-30
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Tesavel : EPAR - Paediatric investigation plan compliance statement
pip-compliance · 2020-06-11
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Tesavel-H-C-PSUSA-00002711-201708: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2018-06-25 · EMA/423578/2018
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Tesavel-H-C-910-P46-0027 : EPAR - Assessment Report
variation-report · 2013-03-27 · EMA/191181/2013
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Tesavel : EPAR - Summary for the public
overview · 2012-12-20
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Tesavel-H-C-910-II-0009 : EPAR - Assessment Report - Variation
variation-report · 2009-12-08 · EMEA/777962/2009
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Tesavel-H-C-910-II-0006 : EPAR - Assessment Report - Variation
variation-report · 2009-10-15 · EMEA/518063/2009
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Tesavel-H-C-910-II-0005 : EPAR - Assessment Report - Variation
variation-report · 2009-07-06 · EMEA/364636/2009
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Tesavel : EPAR - Public assessment report
assessment-report · 2008-02-14
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Tesavel : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2008-02-11
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。