Approval · Notice of Compliance 18182 · 2016
HARVONI: Notice of Compliance 18182
Issued June 14, 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
- 18182
- Date
- June 14, 2016
- Company
- Gilead Sciences Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- Revised indication: use of harvoni in patients 1) with hcv genotype 1 infection and decompensated cirrhosis 2) with hepatitis c recurrence after liver transplantation, and 3) patients with hcv/human immunodeficiency virus 1 co-infection
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| HARVONI | Not yet assigned | — |
Medicinal ingredients
- LEDIPASVIR 90 MG per TAB
- SOFOSBUVIR 400 MG per TAB