跳到正文

法规知识库 · EMA 集中审评

GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.)

budesonide;formoterol fumarate dihydrate · EMEA/H/C/004882 · 已授权

获批上市许可

2020-04-03

欧委会决定日

2025-02-10

持有人 / 申请人

Teva Pharma B.V.

终止日期字段

无

从产品到官方文件

文件记录

6

官方索引 6

EPAR / 审评

4

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:R03AK07

治疗领域:Asthma;Pulmonary Disease, Chronic Obstructive

药理分类:Drugs for obstructive airway diseases

修订号:6 · 最新影响 PI 的程序:R/0016

适应症(原文):Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only. Asthma Budesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: -in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists. or -in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. COPD Symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1) < 70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

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. 2025-02-10 · 欧委会决定

  2. 2020-04-03 · 获批上市许可

  3. 2020-01-30 · 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 4产品信息 2其他 0

EPAR / 审评资料

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

    procedural-steps-after · 2025-02-18

    打开官方文件 ↗
  • GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.) : EPAR - Risk management plan

    rmp · 2024-04-16

    打开官方文件 ↗
  • Budesonide/Formoterol Teva Pharma B.V. : EPAR - Medicine overview

    overview · 2020-04-07 · EMA/118969/2020

    打开官方文件 ↗
  • Budesonide/Formoterol Teva Pharma B.V. : EPAR - Public assessment report

    assessment-report · 2020-04-07 · EMA/83618/2020

    打开官方文件 ↗

产品信息

  • GoResp Digihaler : EPAR - Product Information

    product-information · 2025-02-18

    打开官方文件 ↗
  • GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.) : EPAR - All authorised presentations

    all-authorised-presentations · 2024-04-16

    打开官方文件 ↗

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。