GAZYVA (Roche Products Pty Ltd)
Product name
GAZYVA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
207 (255 working days)
Active ingredients
obinutuzumab
Registration type
EOI
Indication
Lupus Nephritis
Gazyva, is indicated for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis (LN) who are receiving standard therapy.