法规知识库 · EMA 集中审评
INOmax
nitric oxide · EMEA/H/C/000337 · 已授权
获批上市许可
2001-08-01
欧委会决定日
2025-05-15
持有人 / 申请人
Linde Healthcare AB
终止日期字段
无
从产品到官方文件
文件记录
12
官方索引 12
EPAR / 审评
10
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：R07AX
治疗领域：Hypertension, Pulmonary;Respiratory Insufficiency
药理分类：Other respiratory system products
修订号：26 · 最新影响 PI 的程序：N/0000269511
适应症（原文）：INOmax, in conjunction with ventilatory support and other appropriate active substances, is indicated: for the treatment of newborn infants ?34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation; as part of the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation.
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。
2025-05-15 · 欧委会决定
2001-08-01 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
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INOmax : EPAR - Risk management plan
rmp · 2026-01-29
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INOmax : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-01-29
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INOmax : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-03-27
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INOmax : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2023-04-20
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INOmax-H-C-337-P46-18 : EPAR - Assessment Report
variation-report · 2013-02-28
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INOmax : EPAR - Summary for the public
overview · 2013-02-28
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INOmax-H-C-337-P45-19: EPAR - Assessment Report
variation-report · 2012-11-13 · EMEA/307669/2010
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INOmax-H-C-337-II-19 : EPAR - Assessment Report - Variation
variation-report · 2011-04-04 · EMA/231748/2011
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INOmax : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
conditions-member-states · 2011-03-30
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INOmax : EPAR - Scientific Discussion
scientific-discussion · 2006-08-15
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。