Approval · Notice of Compliance 16200 · 2014
SOVALDI: Notice of Compliance 16200
Issued September 30, 2014
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
- 16200
- Date
- September 30, 2014
- Company
- Gilead Sciences Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: for the treatment of hcv genotype 1,2,3 or 4 infection awaiting liver transplantation and those with hcv/hiv-1 co-infection
- Therapeutic class
- Antiviral agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SOVALDI | Not yet assigned | — |
Medicinal ingredients
- SOFOSBUVIR 400 MG per TAB