Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 29 May 2018

Indication(s)

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, see section 4.4 and 5.1.

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More information

Category Value
Agency product number EMEA/H/C/000303
Orphan designation No
Date First Approved 26-03-2001
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Bracco International BV