CADTH is committed to supporting Canada’s health care decision-makers through this challenging and uncertain time.
For evidence, tools, and resources related to COVID-19, visit our COVID-19 Evidence Portal.
|Project Number||pCODR 10033|
|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|
|Review Status||Notification to Implement Issued|
|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|
|Submission Type||New Drug|
|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|
‡ 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.