法规知识库 · EMA 集中审评
Aerivio Spiromax
salmeterol xinafoate;fluticasone propionate · EMEA/H/C/002752 · 已撤市
获批上市许可
2016-08-18
欧委会决定日
2019-10-04
持有人 / 申请人
Teva B.V.
终止日期字段
2019-10-04
从产品到官方文件
文件记录
4
官方索引 4
EPAR / 审评
2
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：R03AK06
治疗领域：Pulmonary Disease, Chronic Obstructive;Asthma
药理分类：Drugs for obstructive airway diseases
修订号：2 · 最新影响 PI 的程序：IAIN/0003
适应症（原文）：Aerivio Spiromax is indicated for use in adults aged 18 years and older only. Asthma Aerivio Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting ?2 agonist) is appropriate: patients not adequately controlled on a lower strength corticosteroid combination product or patients already controlled on a high dose inhaled corticosteroid and long-acting ?2 agonist. Chronic Obstructive Pulmonary Disease (COPD) Aerivio Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.
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。
2019-10-04 · 欧委会决定
2019-10-04 · 上市许可终止（撤市/失效/撤销等）
Withdrawn
2016-08-18 · 获批上市许可
2016-06-23 · 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
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。