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Actos
pioglitazone hydrochloride · EMEA/H/C/000285 · 已授权
获批上市许可
2000-10-13
欧委会决定日
2023-08-11
持有人 / 申请人
CHEPLAPHARM Arzneimittel GmbH
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：A10BG03
治疗领域：Diabetes Mellitus, Type 2
药理分类：Drugs used in diabetes
修订号：30 · 最新影响 PI 的程序：IA/0088/G
适应症（原文）：Pioglitazone is indicated in the treatment of type-2 diabetes mellitus: as monotherapy: in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance; as dual oral therapy in combination with: metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; as triple oral therapy in combination with: metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type-2 diabetes mellitus patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.
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。
2023-08-11 · 欧委会决定
2000-10-13 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
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Actos : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2023-08-28
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Actos : EPAR - Risk-management-plan summary
rmp-summary · 2021-03-04
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Actos-H-C-PSUSA-00002417-201807 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-08-13 · EMA/241761/2019
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Actos : EPAR - Summary for the public
overview · 2016-09-29
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Actos-H-C-PSUSA-00002417-201507 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-06-07 · EMA/391817/2016
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Actos-H-C-285-PSUV-58 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-01-03 · EMA/CHMP/566874/2013
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Actos : EPAR - Conditions imposed on member states for safe and effective use
conditions-member-states · 2012-07-06
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Actos-H-C-285-A20-46 : EPAR – Assessment Report – Article 20
variation-report · 2012-04-26 · EMA/CHMP/940059/2011
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Actos-H-C-285-II-24 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2007-06-11
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Actos-H-C-285-II-25 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2007-06-11
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Actos : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2006-04-03
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Actos : EPAR - Scientific Discussion
scientific-discussion · 2006-04-03
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Actos : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-04-03
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