Approval · Notice of Compliance 35586 · 2025
TABRECTA: Notice of Compliance 35586
Issued June 16, 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
- 35586
- Date
- June 16, 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
- Fulfillment of commitment f of the LOU dated May 12 2022, issued under NDS control #255972.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TABRECTA | Not yet assigned | — |
Medicinal ingredients
- CAPMATINIB HYDROCHLORIDE 150 MG per TAB
- CAPMATINIB HYDROCHLORIDE 200 MG per TAB