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。
2015-07-11 · 上市许可终止(撤市/失效/撤销等)
Expired
2010-12-03 · 欧委会决定
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
- 打开官方文件 ↗
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
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。