Approval · Notice of Compliance 10790 · 2009
SPRYCEL: Notice of Compliance 10790
Issued November 19, 2009
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
- 10790
- Date
- November 19, 2009
- 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
- Fulfilment of commitments as per the Letter of Undertaking, dated March 13, 2007 for the treatment of adults with chronic, accelerated, or blast phase chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy including imatinib mesylate
- 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
- DASATINIB MONOHYDRATE 100 MG per TAB