Approval · Notice of Compliance 11983 · 2011
SPRYCEL: Notice of Compliance 11983
Issued January 4, 2011
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
- 11983
- Date
- January 4, 2011
- 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 strengths: 80 mg and 140 mg tablets
- Therapeutic class
- Protein-tyrosine kinase inhibitor
Products in this notice
Medicinal ingredients
- DASATINIB MONOHYDRATE 80 MG per TAB
- DASATINIB MONOHYDRATE 140 MG per TAB