The FINANCIAL -- Bayer HealthCare successfully completed the
procedure to get approval for use of the contrast medium Gadovist 1.0
in children aged two to six years in the Europe Union and markets like
Germany, France, Spain, Italy and UK, according to Bayer AG.
Use in children aged seven years and above has already been approved since 2009. Germany will start to introduce Gadovist 1.0 for this expanded indication immediately.
Gadovist is approved for the most frequently conducted contrast enhanced magnetic resonance tomography examinations. These include examinations of the central nervous system, blood vessels and imaging of the liver and the kidney. Gadovist has already been approved for this younger patient population in many countries outside the EU incl. the US, Brazil, China, Korea and Canada and was already approved in the EU for kids of seven years and above.
The clinical study, which supports the indication extension for Gadovist, involved 138 children and adolescents who were scheduled for a contrast-enhanced MRT scan. The study investigated the pharmacokinetics as well as the safety and tolerability of Gadovist in young patients. It also undertook an assessment of imaging quality. It was shown that Gadovist is well-tolerated in this patient group too. The study also confirmed that the dosage recommendation based on body weight, which is routine in adults, is also appropriate for the use of Gadovist in children.
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