法规知识库 · EMA 集中审评
Onglyza
saxagliptin · EMEA/H/C/001039 · 已授权
获批上市许可
2009-09-30
欧委会决定日
2023-04-19
持有人 / 申请人
AstraZeneca AB
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：A10BH03
治疗领域：Diabetes Mellitus, Type 2
药理分类：Drugs used in diabetes
修订号：23 · 最新影响 PI 的程序：II/0057
适应症（原文）：Add-on combination therapy Onglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus 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 metformin alone, with diet and exercise, does not provide adequate glycaemic control; in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate; in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate; as triple oral therapy: in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control; as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does 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。
2023-04-19 · 欧委会决定
2009-09-30 · 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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Onglyza : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2024-05-13
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Onglyza : EPAR - Risk-management-plan summary
rmp-summary · 2022-09-22
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Onglyza-H-C-1039-P46-0042 : EPAR - Assessment Report
variation-report · 2017-09-19 · EMA/588971/2017
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Onglyza-H-C-1039-WS-1078 : EPAR - Assessment Report - Variation
variation-report · 2017-07-31 · EMA/CHMP/291920/2017
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Onglyza : EPAR - Summary for the public
overview · 2017-07-31
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Onglyza-H-C-PSUSA-00002685-201407 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-06-08 · EMA/CHMP/305095/2015
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Onglyza-H-C-1039-PSUV-0022 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-09-04 · EMA/CHMP/80911/2014
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Onglyza-H-C-1039-II-0018 : EPAR - Assessment Report - Variation
variation-report · 2013-09-27 · EMA/CHMP/432717/2013
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Onglyza-H-C-1039-PSU-0022 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2013-08-02
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Onglyza-H-C-1039-WS-0295 : EPAR - Assessment Report - Variation
variation-report · 2013-06-14
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Onglyza-H-C-1039-II-0011 : EPAR - Assessment Report - Variation
variation-report · 2012-01-31 · EMA/43321/2012
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Onglyza-H-C-1039-X-0004: EPAR - Assessment Report - Extension
variation-report · 2011-03-29
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Onglyza : EPAR - Public assessment report
assessment-report · 2009-10-27
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。