Approval · Notice of Compliance 26790 · 2021
EPCLUSA: Notice of Compliance 26790
Issued October 6, 2021
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
- 26790
- Date
- October 6, 2021
- Company
- Gilead Sciences Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a new specified degradation product GS-715699 of velpatasvir in the specifications of velpatasvir drug substance, velpatasvir spray-dried dispersion and the drug product Epclusa tablets
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| EPCLUSA | Not yet assigned | — |
Medicinal ingredients
- SOFOSBUVIR 400 MG per TAB
- VELPATASVIR 100 MG per TAB