Approval · Notice of Compliance 18153 · 2016
DAKLINZA: Notice of Compliance 18153
Issued May 17, 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
- 18153
- Date
- May 17, 2016
- Company
- Bristol-Myers Squibb CanadaSt-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- Revised indications: for use in combination with other agents for the treatmen T of chronic hepatitis C (chc) in adult patients with hepatitis C virus (hcv) genotypes 1,2 or 3 including patients with hcv/HIV-1 coinfection, patients with compensated or decompensated cirrhosis (child-pugh score A,B or C, and patients with hcv recurrence after liver transplantation
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DAKLINZA | Not yet assigned | — |
Medicinal ingredients
- DACLATASVIR 30 MG per TAB
- DACLATASVIR 60 MG per TAB