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Project Number | pCODR 10164 |
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Brand Name | Ninlaro |
Generic Name | Ixazomib |
Strength | 4 mg, 3 mg and 2.3 mg |
Tumour Type | Myeloma |
Indication | Multiple Myeloma (2nd-beyond) |
Funding Request | In combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy |
Review Status | Notification to Implement Issued |
Pre Noc Submission | No |
NOC Date | August 4, 2016 |
Manufacturer | Takeda Canada Inc. |
Sponsor | Takeda Canada Inc. |
Submission Date | November 30, 2018 |
Submission Deemed Complete | December 14, 2018 |
Submission Type | New Indication |
Prioritization Requested | |
Stakeholder Input Deadline ‡ | December 14, 2018 |
Check-point meeting | February 7, 2019 |
pERC Meeting | April 18, 2019 |
Initial Recommendation Issued | May 3, 2019 |
Feedback Deadline ‡ | May 17, 2019 |
pERC Reconsideration Meeting | June 20, 2019 |
Final Recommendation Issued | July 5, 2019 |
Notification to Implement Issued | July 22, 2019 |
‡ 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.