PRAC adopted an extension of indication for Gazyvaro for the treatment of adults with active systemic lupus erythematosus receiving standard therapy. (European Medicines Agency) - Oct 25, 2026 - Pharmacovigilance Risk Assessment Committee (PRAC) Minutes
of meeting on 31 Aug – 3 Sep 2026:
The update is based on results from the CA42750 (ALLEGORY) study.
Consequently, sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2, and 6.6 of the SmPC were
updated.
PRAC • Immunology • Systemic Lupus Erythematosus
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