Approval · Notice of Compliance 8911 · 2007
SPRYCEL: Notice of Compliance 8911
Issued July 17, 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
- 8911
- Date
- July 17, 2007
- Company
- Bristol-Myers Squibb CanadaSt-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: for the treatment of adults with philadelphia chromosome positive (ph+) acute lymphoblastic leukemia (all) with resistance or intolerance to prior therapy
- Therapeutic class
- Protein-tyrosine kinase inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SPRYCEL | Not yet assigned | — |
Medicinal ingredients
- DASATINIB MONOHYDRATE 20 MG per TAB
- DASATINIB MONOHYDRATE 50 MG per TAB
- DASATINIB MONOHYDRATE 70 MG per TAB