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| Project Number | PC0215-000 |
|---|---|
| Brand Name | Odomzo |
| Generic Name | Sonidegib |
| Strength | 200 mg |
| Tumour Type | Skin and Melanoma |
| Indication | Basal Cell Carcinoma (BCC) |
| Funding Request | For the treatment of adult patients with histologically confirmed locally advanced basal cell carcinoma (laBCC) that is not amenable to radiation therapy or curative surgery. |
| Review Status | Under Review |
| Pre Noc Submission | No |
| NOC Date | June 12, 2020 |
| Manufacturer | Sun Pharma Canada Inc. |
| Sponsor | Sun Pharma Canada Inc. |
| Submission Date | June 19, 2020 |
| Submission Deemed Complete | July 23, 2020 |
| Submission Type | Initial |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | July 6, 2020 |
| Check-point meeting | September 15, 2020 |
| pERC Meeting | February 18, 2021 |
| Initial Recommendation Issued | March 4, 2021 |
| Feedback Deadline ‡ | March 18, 2021 |
| pERC Reconsideration Meeting (target date) | April 15, 2021 |
| Final Recommendation Issued (target date) | April 29, 2021 |
| Notification to Implement Issued | |
| Therapeutic Area | Basal Cell Carcinoma |
‡ 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.
