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GAZYVA Roche Products Pty Ltd
Product name
GAZYVA
Sponsor
Accepted date
Apr-2026
Active ingredients
obinutuzumab
Summary of proposed indication
GAZYVA (obinutuzumab) is proposed for the treatment of adult patients who are receiving standard therapy for active systemic lupus erythematosus (SLE), a chronic autoimmune disease (where the immune system mistakenly attacks healthy tissues and organs).
Application type
C (new indication)
Publication date
Apr-2026