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|Project Number||pCODR 10103|
|Brand Name||Lynparza (Resubmission)|
|Strength||50 mg capsules|
|Funding Request||As monotherapy maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response to platinum-based chemotherapy|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||No|
|NOC Date||April 29, 2016|
|Manufacturer||AstraZeneca Canada Inc.|
|Sponsor||AstraZeneca Canada Inc.|
|Submission Date||March 17, 2017|
|Submission Deemed Complete||March 31, 2017|
|Prioritization Requested||Requested and Granted|
|Stakeholder Input Deadline ‡||March 31, 2017|
|Check-point meeting||May 15, 2017|
|pERC Meeting||August 17, 2017|
|Initial Recommendation Issued||August 31, 2017|
|Feedback Deadline ‡||September 15, 2017|
|Final Recommendation Issued||September 20, 2017|
|Notification to Implement Issued||October 5, 2017|
‡ 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.