ZEJULA (GlaxoSmithKline Australia Pty Ltd)
Product name
ZEJULA
Date registered
Evaluation commenced
Decision date
Approval time
237 (255 working days)
Active ingredients
niraparib tosilate monohydrate
Registration type
EOI
Indication
ZEJULA (capsule) is now also indicated for the maintenance treatment of adult patients with advanced high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.