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SONOVUE (sulphur hexafluoride), contrast agent

DIAGNOSTIC - New indication
Opinions on drugs - Posted on Oct 24 2018

Reason for request

Extension of indication

High clinical benefit in urinary tract ultrasonography in children (0-18 years) for detecting vesicoureteral reflux and minor clinical added value in the current diagnostic strategy, which includes retrograde urethrocystography techniques, with administration of contrast agents.

 

  • SONOVUE has been granted marketing authorisation for urinary tract ultrasonography in children from birth to 18 years, with a view to detecting vesicoureteral reflux.

  • The efficacy data are based upon 4 clinical studies and one pooled analysis of these 4 studies, comparing urinary tract ultrasonography (UTU) with SONOVUE with retrograde mictional urethrocystography (RMU) to detect vesicoureteral reflux in children. In total, in the 4 studies, approximately 60% additional vesicoureteral reflux diagnoses were made with UTU (329 diagnoses) compared to RMU (195 diagnoses) and 28 cases of vesicoureteral reflux diagnosed with RMU were not observed with UTU.

  • The safety profile of SONOVUE is consistent with that already known in its other indications, and is favourable compared to RMU due to the lack of exposure to ionising radiation.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

minor

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