法规知识库 · EMA 集中审评
Pioglitazone Actavis
pioglitazone hydrochloride · EMEA/H/C/002324 · 已授权
获批上市许可
2012-03-15
欧委会决定日
2023-05-31
持有人 / 申请人
Actavis Group PTC ehf
终止日期字段
无
从产品到官方文件
文件记录
7
官方索引 7
EPAR / 审评
5
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:IG/1612
适应症(原文):Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below: as monotherapy in adult 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 adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin. a sulphonylurea, only in adult 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 adult 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 adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4). 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 (see section 4.4).
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。
2023-05-31 · 欧委会决定
2012-03-15 · 获批上市许可
2012-01-19 · CHMP 意见通过
说明书、EPAR 与其他文件
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EPAR / 审评资料
- 打开官方文件 ↗
Pioglitazone Actavis : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2023-06-01
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Pioglitazone Actavis : EPAR - Risk-management-plan summary
rmp-summary · 2020-09-16
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Pioglitazone Actavis : EPAR - Summary for the public
overview · 2017-01-31
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Pioglitazone Actavis : EPAR - Public assessment report
assessment-report · 2012-04-26 · EMA/210151/2012
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Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use
conditions-member-states · 2012-04-26
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。