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Jakavi for Polycythemia Vera - Details

Project Number pCODR 10065
Brand Name Jakavi
Generic Name Ruxolitinib
Strength 5 mg, 10 mg, 15 mg, 20 mg tablets
Tumour Type Other
Indication Polycythemia vera
Funding Request For the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date November 24, 2015
Manufacturer Novartis Pharmaceuticals Canada Inc.
Submitter Novartis Pharmaceuticals Canada Inc.
Submission Date August 27, 2015
Submission Deemed Complete September 3, 2015
Submission Type New Indication
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ September 11, 2015
Check-point meeting October 20, 2015
pERC Meeting December 17, 2015
Initial Recommendation Issued January 8, 2016
Feedback Deadline ‡ January 22, 2016
pERC Reconsideration Meeting February 18, 2016
Final Recommendation Issued March 3, 2016
Notification to Implement Issued March 18, 2016

‡ 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.