| 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. |
| Sponsor | 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.
