Approval · Notice of Compliance 14169 · 2013
GLEEVEC: Notice of Compliance 14169
Issued February 21, 2013
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
- 14169
- Date
- February 21, 2013
- 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 conditions as per the Letter of undertaking deated May 17, 2007 for the treatment of paediatric patients with newly diagnosed, Philadelphia chromosome positive chronic myeloid leukemia in chronic phase. Fulfillment of conditions as pre the Letter of Undertaking dated December 22, 2004 for the treatment of adult patients with KIT (CD117) positive unresectable and/or metastatic malignamt gastrointestinal stromal tumours>
- Therapeutic class
- Protein kinase inhibitor
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