SonoVue

RSS

sulphur hexafluoride

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for SonoVue. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use SonoVue.

For practical information about using SonoVue, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 25/05/2018

Authorisation details

Product details
Name
SonoVue
Agency product number
EMEA/H/C/000303
Active substance
sulphur hexafluoride
International non-proprietary name (INN) or common name
sulphur hexafluoride
Therapeutic area (MeSH)
  • Ultrasonography
  • Echocardiography
Anatomical therapeutic chemical (ATC) code
V08DA04
Publication details
Marketing-authorisation holder
Bracco International B.V.
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
26/03/2001
Contact address
Strawinskylaan 3051
NL - 1077 ZX Amsterdam
The Netherlands

Product information

26/04/2018 SonoVue - EMEA/H/C/000303 - II/0037/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

CONTRAST MEDIA

Therapeutic indication

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.

Assessment history

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