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法规知识库 · EMA 集中审评

Avandia

rosiglitazone · EMEA/H/C/000268 · 已过期

获批上市许可

2000-07-11

欧委会决定日

2010-12-03

持有人 / 申请人

SmithKline Beecham Plc

终止日期字段

2015-07-11

从产品到官方文件

文件记录

10

官方索引 10

EPAR / 审评

8

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:A10BG02

治疗领域:Diabetes Mellitus, Type 2

药理分类:Drugs used in diabetes

修订号:23 · 最新影响 PI 的程序:A20/0075

适应症(原文):Rosiglitazone 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 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 (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. 2015-07-11 · 上市许可终止(撤市/失效/撤销等)

    Expired

  2. 2010-12-03 · 欧委会决定

  3. 2000-07-11 · 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 8产品信息 2其他 0

EPAR / 审评资料

  • Avandia-H-C-268-A20-75: EPAR - Assessment Report

    variation-report · 2016-06-08 · EMA/831385/2010

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

    procedural-steps-after · 2016-06-08

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  • Avandia : EPAR - Summary for the public

    overview · 2016-06-08

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  • Avandia-H-C-268-II-52 : EPAR - Scientific Discussion - Variation

    scientific-discussion-variation · 2016-06-08

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  • Avandia-H-C-268-II-23 : EPAR - Scientific Discussion - Variation

    scientific-discussion-variation · 2016-06-08

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  • Avandia : EPAR - Steps taken after authorisation when a cutoff date has been used

    steps-after-cutoff · 2016-06-08

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  • Avandia : EPAR - Procedural steps taken before authorisation

    procedural-steps-before · 2016-06-08

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  • Avandia : EPAR - Scientific Discussion

    scientific-discussion · 2016-06-08

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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。