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法规知识库 · EMA 集中审评

SonoVue

sulphur hexafluoride · EMEA/H/C/000303 · 已授权

获批上市许可

2001-03-26

欧委会决定日

2026-03-18

持有人 / 申请人

Bracco International B.V.

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:V08DA05

治疗领域:Ultrasonography;Echocardiography

药理分类:Contrast media

修订号:22 · 最新影响 PI 的程序:EMA/VR/0000337224

适应症(原文):This medicinal product is for diagnostic use only. SonoVue is for use with ultrasound imaging to enhance the echogenicity of the blood, or of fluids in the urinary tract which results in an improved signal to noise ratio. SonoVue should only be used in patients where study without contrast enhancement is inconclusive. Echocardiography SonoVue is a transpulmonary echocardiographic contrast agent for use in adult patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation. Doppler of macrovasculature SonoVue increases the accuracy in detection or exclusion of abnormalities in cerebral arteries and extracranial carotid or peripheral arteries in adult patients by improving the Doppler signal to noise ratio. SonoVue increases the quality of the Doppler flow image and the duration of clinically useful signal enhancement in portal vein assessment in adult patients. Doppler of microvasculature SonoVue improves display of the vascularity of liver and breast lesions during Doppler sonography in adult patients leading to more specific lesion characterisation. Ultrasonography of excretory urinary tract SonoVue is indicated for use in ultrasonography of the excretory tract in paediatric patients from newborn to 18 years to detect vesicoureteral reflux. For the limitation in the interpretation of a negative urosonography.

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. 2026-03-18 · 欧委会决定

  2. 2001-03-26 · 获批上市许可

说明书、EPAR 与其他文件

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EPAR / 审评资料 10产品信息 2其他 0

EPAR / 审评资料

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

    procedural-steps-after · 2026-03-20

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  • SonoVue : EPAR - Risk management plan

    rmp · 2025-11-24

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  • SonoVue : EPAR - Procedural steps taken and scientific information after authorisation (archive)

    procedural-steps-after · 2025-11-24

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  • SonoVue-H-C-PSUSA-00002822-202009 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2021-09-14 · EMA/359079/2021

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  • SonoVue-H-C-303-X-0034-G : EPAR - Assessment Report - Variation

    variation-report · 2017-08-24 · EMA/CHMP/431946/2017

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  • SonoVue : EPAR - Summary for the public

    overview · 2017-08-24

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  • SonoVue-H-C-303-II-0025 : EPAR - Assessment Report - Variation

    variation-report · 2014-07-29 · EMA/454283/2014

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  • SonoVue : EPAR - Steps taken after authorisation when a cutoff date has been used

    steps-after-cutoff · 2005-10-21

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  • SonoVue : EPAR - Procedural steps taken before authorisation

    procedural-steps-before · 2005-10-21

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  • SonoVue : EPAR - Scientific Discussion

    scientific-discussion · 2005-10-21

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产品信息

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。