Approval · Notice of Compliance 17533 · 2015
SPRYCEL: Notice of Compliance 17533
Issued November 26, 2015
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
- 17533
- Date
- November 26, 2015
- 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
- To fulfill the conditions of authorization for the treatment of adults with newly diagnosed philadelphia chromosome positive chronic myeloid leukemia in chronic phase; and to update the product monograph with longer term data from studies ca 180056 and ca 180034
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 80 MG per TAB
- DASATINIB MONOHYDRATE 100 MG per TAB
- DASATINIB MONOHYDRATE 140 MG per TAB