The Pharmacovigilance Risk Assessment Committee (PRAC) recommends a Europe-wide suspension of fenspiride-containing medicinal products used in children and adults to relieve cough due to lung diseases. This recommendation is based on reports of patients with cardiac arrhythmias who have used the above medicines in the past, and tests have shown that the active substance fenspiride may prolong QT in humans.
While the PRAC is reviewing the results, it recommends that the approval of fenspirid-containing medicinal products be suspended for the time being. Fenspirid is approved in several EU countries. However, the active ingredient is not approved in Germany, for example.
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