Approval · Notice of Compliance 8637 · 2007
GLEEVEC: Notice of Compliance 8637
Issued March 8, 2007
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
- 8637
- Date
- March 8, 2007
- 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
- New indication: for use as a single agent for induction phase therapy in adult patients with newly diagnosed philadelphia chromosome-positive acute lymphoblastic leukemia (ph+all); and for the treatment of adult patients with relapsed or refractory ph+all as monotherapy
- Therapeutic class
- Protein kinase inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| GLEEVEC | Not yet assigned | — |
Medicinal ingredients
- IMATINIB MESYLATE 100 MG per CAP
- IMATINIB MESYLATE 100 MG per TAB
- IMATINIB MESYLATE 400 MG per TAB