Last Updated : September 21, 2020
Details
FilesGeneric Name:
Niraparib
Project Status:
Complete
Therapeutic Area:
Ovarian Cancer
Manufacturer:
GlaxoSmithKline Inc.
Brand Name:
Zejula
Project Line:
Reimbursement Review
Project Number:
PC0203-000
NOC Status at Filing:
Post NOC
Strength:
100 mg
Tumour Type:
Gynecology
Indications:
Ovarian Cancer
Funding Request:
As monotherapy for the maintenance treatment of female adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
Sponsor:
GlaxoSmithKline Inc.
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation Issued (target date):
pERC Meeting:
Final Recommendation Issued:
Files
‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.
Last Updated : September 21, 2020