Approval · Notice of Compliance 18092 · 2016
HARVONI: Notice of Compliance 18092
Issued May 12, 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
- 18092
- Date
- May 12, 2016
- Company
- Gilead Sciences Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of an alternate drug substance manufacturing site
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| HARVONI | Not yet assigned | — |
Medicinal ingredients
- LEDIPASVIR 90 MG per TAB
- SOFOSBUVIR 400 MG per TAB