WHO Alert on Falsified DEFITELIO (Defibrotide) 80 mg/mL Concentrate for Solution for Infusion Identified in India

Gentium S.r.l., the Marketing Authorisation Holder of DEFITELIO® (Defibrotide) 80 mg/mL, received an authenticity inquiry from India regarding a product labelled with batch number 24GC01A and expiry date April 2027. Comparative assessment against authentic reference samples revealed significant differences in packaging design, font style, artwork and overall presentation, confirming the product as falsified.   Although the batch and serial numbers correspond to a genuine batch, the packaging was determined to be fraudulent. The authentic batch had been distributed only to selected countries including the United Arab Emirates, Cyprus, Spain, Finland, Israel, Portugal, Sweden, Slovenia, Turkey and Uruguay. DEFITELIO is not authorized for marketing in India.   The Marketing Authorisation Holder has reported only a single incident, and no recall has been initiated because there is no evidence of broader distribution. Investigations remain ongoing.