Approval · Notice of Compliance 18665 · 2016
DAKLINZA: Notice of Compliance 18665
Issued November 9, 2016
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
- 18665
- Date
- November 9, 2016
- 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 remove the conditions of noc/C for use of daklinza in combination with other agents for the treatment of chronic hepatitis C (chc) in adult patients with hepatitis C virus (hcv) genotype 3 and compensated liver disease, including cirrhosis
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DAKLINZA | Not yet assigned | — |
Medicinal ingredients
- DACLATASVIR 30 MG per TAB
- DACLATASVIR 60 MG per TAB