Approval · Notice of Compliance 35017 · 2025
TAFINLAR: Notice of Compliance 35017
Issued March 14, 2025
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.
- Notice number
- 35017
- Date
- March 14, 2025
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a manufacturing site and/or manufacturer involving production of the drug substance. Change in the manufacturing process for the drug substance.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TAFINLAR | Not yet assigned | — |
Medicinal ingredients
- DABRAFENIB MESYLATE 50 MG per CAP
- DABRAFENIB MESYLATE 75 MG per CAP
- DABRAFENIB MESYLATE 10 MG per TAB