Approval · Notice of Compliance 24569 · 2020
EPCLUSA: Notice of Compliance 24569
Issued November 6, 2020
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
- 24569
- Date
- November 6, 2020
- Company
- Gilead Sciences Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To expand the indication for epclusa to include pediatric patients >12 years of age or weighing >30 kg without cirrhosis or with compensated cirrhosis
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| EPCLUSA | Not yet assigned | — |
Medicinal ingredients
- SOFOSBUVIR 400 MG per TAB
- VELPATASVIR 100 MG per TAB