Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: SonoVue   
Auth. number : EU/1/01/177
Active substance : sulphur hexafluoride
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V08 - Contrast media
Pharmacological subgroup: V08D - Ultrasound contrast media
Chemical subgroup: V08DA - Ultrasound contrast media
Chemical substance: V08DA05 - sulfur hexafluoride
(See WHO ATC Index)
Indication: This medicinal product is for diagnostic use only.
SonoVue is for use with ultrasound imaging to enhance the echogenicity of the blood, 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 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 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.

Doppler of microvasculature
SonoVue improves display of the vascularity of liver and breast lesions during Doppler sonography, 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.
Marketing Authorisation Holder: Bracco International B.V.
Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
29/03/2001 Centralised - Authorisation EMEA/H/C/303 (2001)795 of 26/03/2001
04/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/303/II/1
21/02/2002 Centralised - Notification EMEA/H/C/303/N/2 (2002)632 of 19/02/2002
01/05/2002 Centralised - Notification EMEA/H/C/303/N/3 (2002)1825 of 29/04/2002
09/12/2002 Centralised - Variation EMEA/H/C/303/II/4 (2002)4960 of 04/12/2002
27/03/2003 Centralised - Notification EMEA/H/C/303/N/5 (2003)1038 of 24/03/2003
29/09/2004 Centralised - Variation EMEA/H/C/303/II/7 (2004)3652 of 27/09/2004
26/04/2006 Centralised - Renewal EMEA/H/C/303/R/8 (2006)1744 of 24/04/2006
09/06/2006 Centralised - Variation EMEA/H/C/303/IA/10
Updated with Decision(2006)7085 of 19/12/2006
09/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/303/IA/9
21/12/2006 Centralised - Variation (2006)7085 of 19/12/2006
31/01/2008 Centralised - Variation EMEA/H/C/303/IA/12
Updated with Decision(2008)4958 of 02/09/2008
31/01/2008 Centralised - Notification EMEA/H/C/303/N/13
Updated with Decision(2008)4958 of 02/09/2008
04/09/2008 Centralised - Variation (2008)4958 of 02/09/2008
26/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/303/II/15
22/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/303/IA/16
24/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/303/IB/18/G
25/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/303/IA/19
27/01/2011 Centralised - Variation EMEA/H/C/303/II/17 (2011)470 of 24/01/2011
26/10/2012 Centralised - Variation EMEA/H/C/303/II/21 (2012)7662 of 24/10/2012
02/05/2014 Centralised - Variation EMEA/H/C/303/II/25
Updated with Decision(2015)2524 of 13/04/2015
15/04/2015 Centralised - Yearly update (2015)2524 of 13/04/2015
23/06/2015 PSUSA - Modification EMEA/H/C/303/PSUSA/2822 (2015)4314 of 19/06/2015
24/05/2016 Centralised - Notification EMEA/H/C/303/N/31
Updated with Decision(2017)5890 of 22/08/2017
24/08/2017 Centralised - Variation EMEA/H/C/303/X/34 (2017)5890 of 22/08/2017
24/08/2017 Corrigendum (2017)5890 of 22/08/2017
26/03/2018 Corrigendum (2017)5890 of 22/08/2017