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法规知识库 · EMA 集中审评

Dapagliflozin Viatris

dapagliflozin · EMEA/H/C/006006 · 已授权

仿制药

获批上市许可

2023-03-24

欧委会决定日

2026-05-05

持有人 / 申请人

Viatris Limited

终止日期字段

无

从产品到官方文件

文件记录

7

官方索引 7

EPAR / 审评

5

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:A10BK01

治疗领域:Diabetes Mellitus, Type 2;Heart Failure, Systolic;Heart Failure;Renal Insufficiency, Chronic

药理分类:Drugs used in diabetes

修订号:6 · 最新影响 PI 的程序:VR/0000325156

适应症(原文):Type 2 diabetes mellitus Dapagliflozin Viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure Dapagliflozin Viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. Chronic kidney disease Dapagliflozin Viatris is indicated in adults for the treatment of chronic kidney disease.

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. 2026-05-05 · 欧委会决定

  2. 2023-03-24 · 获批上市许可

  3. 2023-01-26 · 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 5产品信息 2其他 0

EPAR / 审评资料

  • Dapagliflozin Viatris : EPAR - Procedural steps taken and scientific information after the authorisation

    procedural-steps-after · 2026-05-07

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  • Dapagliflozin Viatris : EPAR - Procedural steps taken and scientific information after the authorisation (archive)

    procedural-steps-after · 2026-01-26

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  • Dapagliflozin Viatris : EPAR - Medicine Overview

    overview · 2023-04-04 · EMA/69114/2023

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  • Dapagliflozin Viatris : EPAR - Risk management plan summary

    rmp-summary · 2023-04-04

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  • Dapagliflozin Viatris : EPAR - Public Assessment Report

    assessment-report · 2023-04-04 · EMA/68353/2023

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产品信息

  • Dapagliflozin Viatris : EPAR - Product Information

    product-information · 2026-05-07

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  • Dapagliflozin Viatris : EPAR - All authorised presentations

    all-authorised-presentations · 2023-04-04

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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。