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| 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. |
| Sponsor | 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.
