法规知识库 · EMA 集中审评
Pioglitazone Accord
pioglitazone hydrochloride · EMEA/H/C/002277 · 已授权
获批上市许可
2012-03-21
欧委会决定日
2024-08-19
持有人 / 申请人
Accord Healthcare S.L.U.
终止日期字段
无
从产品到官方文件
文件记录
8
官方索引 8
EPAR / 审评
6
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：A10BG03
治疗领域：Diabetes Mellitus, Type 2
药理分类：Drugs used in diabetes
修订号：9 · 最新影响 PI 的程序：EMA/VR/0000225173
适应症（原文）：Pioglitazone is indicated in the treatment of type-2 diabetes mellitus: as monotherapy in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
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。
2024-08-19 · 欧委会决定
2012-03-21 · 获批上市许可
2012-01-19 · 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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Pioglitazone Accord : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2024-08-27
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Pioglitazone Accord : EPAR - Procedural steps taken and scientific information after authorisation (archived)
procedural-steps-after · 2024-08-27
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Pioglitazone Accord : EPAR - Risk-management-plan summary
rmp-summary · 2021-02-26
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Pioglitazone Accord : EPAR - Summary for the public
overview · 2017-05-17 · EMA/684102/2011
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Pioglitazone Accord : EPAR - Conditions imposed on member states for safe and effective use
conditions-member-states · 2012-04-26
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Pioglitazone Accord : EPAR - Public assessment report
assessment-report · 2012-04-26 · EMA/CHMP/46573/2012
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。