法规知识库 · EMA 集中审评
Nyracta
rosiglitazone · EMEA/H/C/000269 · 已撤市
获批上市许可
2000-07-11
欧委会决定日
2004-12-08
持有人 / 申请人
SmithKline Beecham Plc
终止日期字段
2004-12-08
从产品到官方文件
文件记录
0
官方索引 0
EPAR / 审评
0
assessment / overview 等
产品信息
0
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:6 · 最新影响 PI 的程序:—
适应症(原文):Rosiglitazone is indicated as oral monotherapy in type 2 diabetes mellitus patients, particularly overweight patients, inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. Rosiglitazone is also indicated for oral combination treatment in type 2 diabetes mellitus patients with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy with either metformin or a sulphonylurea:- in combination with metformin particularly in overweight patients.- in combination with a sulphonylurea only in patients who show intolerance to metformin or for whom metformin is contraindicated.
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。
2004-12-08 · 欧委会决定
2004-12-08 · 上市许可终止(撤市/失效/撤销等)
Withdrawn
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。
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。