Approval · Notice of Compliance 19343 · 2017
HARVONI: Notice of Compliance 19343
Issued May 24, 2017
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
- 19343
- Date
- May 24, 2017
- Company
- Gilead Sciences Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- Treatment indication to include adolescent patients (from 12 years of age) with chronic hepatitis C virus genotype 1 infection, without cirrhosis or with compensated cirrhosis
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| HARVONI | Not yet assigned | — |
Medicinal ingredients
- LEDIPASVIR 90 MG per TAB
- SOFOSBUVIR 400 MG per TAB