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|Generic Name||Arsenic Trioxide|
|Indication||Acute Promyelocytic Leukemia|
|Funding Request||For patients who were refractory to or relapsed from previous treatment and newly diagnosed APL patients who have received no prior treatment|
|Pre Noc Submission||No|
|NOC Date||June 7, 2013|
|Manufacturer||Lundbeck Canada Inc.|
|Sponsor||Lundbeck Canada Inc.|
|Submission Date||August 30, 2013|
|Submission Deemed Complete||September 9, 2013|
|Prioritization Requested||Requested and Granted|
|Stakeholder Input Deadline ‡||September 16, 2013|
|Check-point meeting||November 12, 2013|
|pERC Meeting||January 16, 2014|
|Initial Recommendation Issued||January 30, 2014|
|Feedback Deadline ‡||February 13, 2014|
|Final Recommendation Issued||February 18, 2014|
|Notification to Implement Issued||March 5, 2014|
|Therapeutic Area||Acute Promyelocytic Leukemia|
‡ 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.