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Bendamustine hydrochloride: CMDh Scientific conclusions and grounds for variation, amendments to the

PRAC reviewed the available post marketing safety data, published literature and data from clinical trials. PRAC concluded that a causal association could be established for the below listed ADR , based on the number of cases over time, the temporal association in the majority of cases, the known mode of action of bendamustine, and the absence of plausible alternative etiologies in some of the cases reviewed: Opportunistic infection (including Herpes zoster, cytomegalovirus, hepatitis B); Pneumocystis jirovecii pneumonia; Pancytopenia; Bone marrow failure; Headache; Dizziness; Atrial fibrillation; Stevens – Johnson syndrome, Toxic Epidermal Necrolysis (TEN); Renal failure; Myelodysplastic syndrome, acute myeloid leukemia.


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