| Project Number | pCODR 10012 |
|---|---|
| Brand Name | Jakavi |
| Generic Name | Ruxolitinib |
| Strength | 5mg, 15mg, and 20mg |
| Tumour Type | Other |
| Indication | Myelofibrosis |
| Funding Request | For the treatment of patients with myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | No |
| NOC Date | June 19, 2012 |
| Manufacturer | Novartis Pharmaceuticals Canada Inc. |
| Sponsor | Novartis Pharmaceuticals Canada Inc. |
| Submission Date | June 25, 2012 |
| Submission Deemed Complete | July 3, 2012 |
| Submission Type | New Drug |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | July 10, 2012 |
| Check-point meeting | August 15, 2012 |
| pERC Meeting | October 18, 2012 |
| Initial Recommendation Issued | November 1, 2012 |
| Feedback Deadline ‡ | November 16, 2012 |
| pERC Reconsideration Meeting | December 20, 2012 |
| Final Recommendation Issued | January 14, 2013 |
| Notification to Implement Issued | January 29, 2013 |
‡ 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.
