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  • Information appeal regarding to the drug Amispiron IC Information appeal regarding to the drug Amispiron IC The Pharmacovigilance Risk Assessment Committee EMA (PRAC) recommended temporarily to stop usingdrugs containing fenspiride. Suspension is a precautionary measure to protect patients during PRAC review of evidence of the risk of prolonged QT interval and torsades de pointes (disturbances in the electrical activity of the heart, which may lead to disturbances in the heart rhythm). On the basis of PRAC data and in accordance to the legislation of Ukraine, the State Drugs and Medication Central Service of Ukraine temporarily stop the sale and...
  • Information of the State Expert Center of the MoH Ukraine about the drugs which contain fenspiridum, in the EU Information of the State Expert Center of the MoH Ukraine about the drugs which contain fenspiridum, in the EU EMA’s safety committee (PRAC) has recommended an EU-wide suspension of fenspiride medicines, used in children and adults to relieve cough caused by lung diseases. The suspension is a precautionary measure to protect patients while the PRAC reviews the risk of QT prolongation and torsades de pointes (abnormalities of the heart’s electrical activity that may lead to heart rhythm disturbances). Cases of heart rhythm problems had been reported in patients who had taken these medicines in the past. To explore the potential link between...