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Direct Healthcare Professional Communication (DHPC) on tolperisone: a reminder of the negative risk-benefit balance if the use is outside the authorised indication
2020.06.02
Active substance: tolperisone
In agreement with the European Medicines Agency (EMA) and the German Federal Institute for Drugs and Medical Devices (BfArM), the marketing authorisation holders of tolperisone containing drugs are once again informing, that since 2013 tolperisone is only authorised for the symptomatic treatment of spasticity after a stroke in adult patients. Only in this indication the benefits outweigh the potential risks.
Download DHPC / Information letter , Download_VeroeffentlichtAm_EN