Approval · Notice of Compliance 34240 · 2024
RETEVMO: Notice of Compliance 34240
Issued October 21, 2024
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 34240
- Date
- October 21, 2024
- Company
- Loxo Oncology Inc
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Fulfillment of commitment(s) [commitment #1] of the LOU dated [June 8-2021], issued under NDS control # 243748]
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RETEVMO | Not yet assigned | — |
Medicinal ingredients
- SELPERCATINIB 40 MG per CAP
- SELPERCATINIB 80 MG per CAP