Agency for Medicinal Products and Medical Devices of BiH recently issued temporary decisions on suspension of three medications in BiH, and instructed measures of withdrawing them from the market of BiH.
They are Escontral direkt (desloratadine), 30×5 mg, produced by Jadran Galenski laboratory, Croatia; Escitalopram PharmaS (escitalopram), 28×10 mg, produced by PharmaS d.o.o., Croatia; and Tramado/Paracetamol PharmaS (tramadol, paracetamol), (37.5 mg + 325 mg), produced by PharmaS d.o.o., Croatia.
Director of the Agency Nataša Grubiša told FENA they are precautionary measures, that the cause of withdrawal is not security issue, and that the Agency will follow every decision of the European Medicines Agency and Croatian Medicines Agency and act accordingly.
Temporary suspension of the three medications in BiH was issued based on recommendation of the European Medicines Agency (EMA), and they are measures that were issued due to deviations from principles of good clinical practice in clinical studies of those medications. Deviations were determined by the French Medicines Agency during inspection supervision which resulted in the aforementioned recommendation by the EMA, and then regulatory measures of Croatian Agency for Medicinal Products and Medical Devices. Temporary suspension of nine medicines was issued in Croatia, and out of those nine three were registered in BiH.
(Source: Fena/ photo 072info)
