Approval · Notice of Compliance 33722 · 2024
TABRECTA: Notice of Compliance 33722
Issued July 29, 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.
- Notice number
- 33722
- Date
- July 29, 2024
- 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. Change in the specification for the drug product
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