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Treanda for indolent Non-Hodgkin Lymphoma

Project Number pCODR 10010
Brand Name Treanda
Generic Name Bendamustine hydrochloride
Strength 25 mg/vial and 100 mg/vial
Tumour Type Lymphoma
Indication Non-Hodgkin lymphoma (NHL)
Funding Request For patients with indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma (first line and relapse/refractory)
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date August 24, 2012
Manufacturer Lundbeck Canada Inc.
Submitter Lundbeck Canada Inc.
Submission Date April 24, 2012
Submission Deemed Complete May 1, 2012
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ May 8, 2012
Check-point meeting June 27, 2012
pERC Meeting September 20, 2012
Initial Recommendation Issued October 4, 2012
Feedback Deadline ‡ October 19, 2012
pERC Reconsideration Meeting November 15, 2012
Final Recommendation Issued November 29, 2012
Notification to Implement Issued December 14, 2012

‡ 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.