Approval · Notice of Compliance 19078 · 2017
HARVONI: Notice of Compliance 19078
Issued February 13, 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
- 19078
- Date
- February 13, 2017
- Company
- Gilead Sciences Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- For the treatment of: chronic hepatitis C virus (hcv) genotypes (gt) 2, 3, 4, 5 or 6 infection, without cirrhosis or with compensated cirrhosis. chronic hcv gt4/HIV-1 co-infected adults. chronic hcv gt4 in liver transplant recipients, with or without compensated cirrhosis. optional dosing regimen for gt1 treatment-experienced patients with 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