PRAC adopted safety updates to the product information to include progressive multifocal leukoencephalopathy as an adverse drug reaction with a frequency of not known, based on post-marketing data and published literature. (European Medicines Agency) - Oct 25, 2026 - Pharmacovigilance Risk Assessment Committee (PRAC) Minutes
of meeting on 31 Aug – 3 Sep 2026:
Consequently, sections 4.4 and 4.8 of the SmPC were updated, with
corresponding revisions to the Package Leaflet. RMP version 7 was also
submitted.
PRAC • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Non-Hodgkin's Lymphoma • Oncology
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