跳到正文

法规知识库 · EMA 集中审评

Incresync

alogliptin;pioglitazone · EMEA/H/C/002178 · 已授权

获批上市许可

2013-09-19

欧委会决定日

2022-09-07

持有人 / 申请人

Takeda Pharma A/S

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:A10BD09

治疗领域:Diabetes Mellitus, Type 2

药理分类:Drugs used in diabetes;Combinations of oral blood glucose lowering drugs

修订号:13 · 最新影响 PI 的程序:N/0043

适应症(原文):Incresync is indicated as a second- or third-line treatment in adult patients aged 18 years and older with type-2 diabetes mellitus: as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance; in combination with metformin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone. In addition, Incresync can be used to replace separate tablets of alogliptin and pioglitazone in those adult patients aged 18 years and older with type-2 diabetes mellitus already being treated with this combination. After initiation of therapy with Incresync, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, Incresync should be discontinued. In light of potential risks with prolonged pioglitazone therapy, prescribers should confirm at subsequent routine reviews that the benefit of Incresync 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。

  1. 2022-09-07 · 欧委会决定

  2. 2013-09-19 · 获批上市许可

  3. 2013-07-25 · 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 6产品信息 2其他 0

EPAR / 审评资料

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

    procedural-steps-after · 2022-09-09

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

    overview · 2021-10-04 · EMA/494300/2021

    打开官方文件 ↗
  • Incresync-H-C-PSUSA-00010061-202004 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

    scientific-conclusion · 2021-03-31 · EMA/134473/2021

    打开官方文件 ↗
  • Incresync : EPAR - Risk-management-plan summary

    rmp-summary · 2020-04-02

    打开官方文件 ↗
  • Incresync-H-C-2178-PSUV-0008 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

    scientific-conclusion · 2015-02-05 · EMA/CHMP/26411/2015

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

    assessment-report · 2013-10-14 · EMA/CHMP/208477/2013

    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。