sulphur hexafluoride

This medicine is authorised for use in the European Union.


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 05/06/2023

Authorisation details

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

Product information

10/11/2022 SonoVue - EMEA/H/C/000303 - PSUSA/00002822/202009

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.


Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.


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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