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ZEJULA (Takeda Pharmaceuticals Australia Pty Ltd)
Product name
ZEJULA
Date registered
Evaluation commenced
Decision date
Approval time
180 working days (255)
Active ingredients
niraparib (as tosilate monohydrate)
Registration type
NCE/NBE
Indication
ZEJULA (capsules) is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.