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|Project Number||pCODR 10207|
|Strength||25 mg and 100 mg|
|Indication||Acute Myeloid Leukemia (AML)|
|Funding Request||In combination with low-dose cytarabine, for the treatment of newly diagnosed and previously untreated acute myeloid leukemia (AML) in adult patients, who are age ≥75 years or who are not eligible to receive intensive induction chemotherapy.|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||Yes|
|NOC Date||April 28, 2020|
|Manufacturer||Pfizer Canada ULC|
|Sponsor||Pfizer Canada ULC|
|Submission Date||May 6, 2020|
|Submission Deemed Complete||June 18, 2020|
|Submission Type||New Drug|
|Stakeholder Input Deadline ‡||May 21, 2020|
|Check-point meeting||July 29, 2020|
|pERC Meeting||October 15, 2020|
|Initial Recommendation Issued||October 29, 2020|
|Feedback Deadline ‡||November 12, 2020|
|pERC Reconsideration Meeting||December 17, 2020|
|Final Recommendation Issued||January 8, 2021|
|Notification to Implement Issued||January 25, 2021|
‡ 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.