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| Project Number | pCODR 10015 |
|---|---|
| Brand Name | Erivedge |
| Generic Name | Vismodegib |
| Strength | 150 mg capsule |
| Tumour Type | Skin and Melanoma |
| Indication | Advanced Basal Cell Carcinoma |
| Funding Request | For the treatment of adult patients with histologically confirmed metastatic basal cell carcinoma or with locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | July 12, 2013 |
| Manufacturer | Hoffmann-La Roche Limited |
| Sponsor | Hoffmann-La Roche Limited |
| Submission Date | June 14, 2013 |
| Submission Deemed Complete | June 21, 2013 |
| Submission Type | New Drug |
| Prioritization Requested | Requested and Granted |
| Stakeholder Input Deadline ‡ | June 28, 2013 |
| Check-point meeting | August 28, 2013 |
| pERC Meeting | October 17, 2013 |
| Initial Recommendation Issued | October 31, 2013 |
| Feedback Deadline ‡ | November 15, 2013 |
| pERC Reconsideration Meeting | December 19, 2013 |
| Final Recommendation Issued | January 10, 2014 |
| Notification to Implement Issued | January 27, 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.
