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Trisenox for Acute Promyelocytic Leukemia - Details

Project Number pCODR 10033
Brand Name Trisenox
Generic Name Arsenic Trioxide
Strength 1 mg/mL
Tumour Type Leukemia
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.