PRAC confirmed that the benefit-risk balance of Lunsumio remains unchanged in its approved indication following a review of safety and efficacy data. (European Medicines Agency) - Oct 1, 2026 - Pharmacovigilance Risk
Assessment Committee (PRAC) Minutes of meeting on 6 – 9 Jul 2026: The
product information was updated to include a warning on opportunistic
infections and to add viral, bacterial and fungal infections as undesirable
effects, with frequencies specified by severity. The terms of the marketing
authorisation were varied accordingly. [AI generated summary]
PRAC • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Large B Cell Lymphoma • Oncology
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