Approval · Notice of Compliance 10258 · 2009
SPRYCEL: Notice of Compliance 10258
Issued June 18, 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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 10258
- Date
- June 18, 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
- Study: Commitment # 4 of the Letter of Undertaking dated March 13, 2007 - final results of a pharmacokinetic study of SPRYCEL in subjects with hepatic impairment. Revised Product Monograph: Changes to Warnings and Precautions, Dosage and Administration, Action and Clinical Pharmacology
- Therapeutic class
- Protein-tyrosine kinase inhibitor
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SPRYCEL | Not yet assigned | — |
Medicinal ingredients
- DASATINIB MONOHYDRATE 50 MG per TAB
- DASATINIB MONOHYDRATE 20 MG per TAB
- DASATINIB MONOHYDRATE 70 MG per TAB
- DASATINIB MONOHYDRATE 100 MG per TAB