🇪🇺 SonoVue® in European Union

EMA authorised SonoVue® on 26 March 2001

Marketing authorisation

EMA — authorised 26 March 2001

  • Application: EMEA/H/C/000303
  • Marketing authorisation holder: Bracco International B.V.
  • Local brand name: SonoVue
  • 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 macrov
  • Status: approved

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Frequently asked questions

Is SonoVue® approved in European Union?

Yes. EMA authorised it on 26 March 2001.

Who is the marketing authorisation holder for SonoVue® in European Union?

Bracco International B.V. holds the EU marketing authorisation.