Approval · Notice of Compliance 26148 · 2021
HARVONI: Notice of Compliance 26148
Issued June 25, 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
- 26148
- Date
- June 25, 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
- To update the Adverse Reactions and Patient Medication Information sections of the Product Monograph with the postmarket adverse reaction of Stevens-Johnson Syndrome (SJS)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| HARVONI | Not yet assigned | — |
Medicinal ingredients
- LEDIPASVIR 90 MG per TAB
- SOFOSBUVIR 400 MG per TAB