Approval · Notice of Compliance 8672 · 2007
SPRYCEL: Notice of Compliance 8672
Issued March 26, 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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 8672
- Date
- March 26, 2007
- Company
- Bristol-Myers Squibb CanadaSt-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- Therapeutic class
- Protein-tyrosine kinase inhibitor
- With conditions
- Yes (NOC/c)
Products in this notice
Medicinal ingredients
- DASATINIB MONOHYDRATE 20 MG per TAB
- DASATINIB MONOHYDRATE 50 MG per TAB
- DASATINIB MONOHYDRATE 70 MG per TAB