At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies. The Committee did not start or conclude any referral procedures. More information on all safety reviews currently under evaluation is provided in the ‘Ongoing referrals’ table. Information on all topics discussed by the PRAC is available in the agenda.
New safety information for healthcare professionals
As part of its advice on safety-related aspects to other EMA committees, the PRAC discussed a direct healthcare professional communication (DHPC) containing important information for Defitelio.
Defitelio: Should not be used for prevention of veno-occlusive disease (VOD)
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…