Approval · Notice of Compliance 20111 · 2017
GLEEVEC: Notice of Compliance 20111
Issued November 24, 2017
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
- 20111
- Date
- November 24, 2017
- 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
- Fulfilment of the final Post-Approval Commitment for the Notice of Compliance with conditions for the adjuvant treatment of adult patients who are at intermediate to high risk of relapse following complete resection of Kit (CD117) positive Gastrointestinal Stromal Tumors (GIST)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| GLEEVEC | Not yet assigned | — |
Medicinal ingredients
- IMATINIB MESYLATE 100 MG per TAB
- IMATINIB MESYLATE 400 MG per TAB