PRAC May 2022 – Discussion regarding a direct healthcare professional communication (DHPC) containing important information for Defitelio

May 16, 2022

During its April 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) discussed a direct healthcare professional communication (DHPC) containing important information for Defitelio. 

Source: FAMHP

This DHPC informs healthcare professionals about the result of a study which compared Defitelio (defibrotide) in combination with best supportive care (BSC) with BSC alone, when used for prophylaxis (prevention of) veno-occlusive disease (VOD) after hematopoietic stem-cell transplantation (HSCT). Prophylaxis of VOD is not an authorised indication for Defitelio.

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