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法规知识库 · EMA 集中审评

Paglitaz

pioglitazone hydrochloride · EMEA/H/C/002309 · 已失效

仿制药

获批上市许可

2012-03-21

欧委会决定日

2014-01-15

持有人 / 申请人

KRKA tovarna zdravil d.d. Novo mesto

终止日期字段

2015-03-27

从产品到官方文件

文件记录

6

官方索引 6

EPAR / 审评

4

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:1 · 最新影响 PI 的程序:IB/0002

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 in adult patients with insufficient glycaemic control on insulin 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。

  1. 2015-03-27 · 上市许可终止(撤市/失效/撤销等)

    Lapsed

  2. 2014-01-15 · 欧委会决定

  3. 2012-03-21 · 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 4产品信息 2其他 0

EPAR / 审评资料

  • Paglitaz : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2014-07-14

    打开官方文件 ↗
  • Paglitaz : EPAR - Conditions imposed on member states for safe and effective use

    conditions-member-states · 2012-04-26

    打开官方文件 ↗
  • Paglitaz : EPAR - Public assessment report

    assessment-report · 2012-04-26 · EMA/183894/2012

    打开官方文件 ↗
  • Paglitaz : EPAR - Summary for the public

    overview · 2012-04-26 · EMA/684024/2011

    打开官方文件 ↗

产品信息

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。