Approval · Notice of Compliance 30548 · 2023
BIKTARVY: Notice of Compliance 30548
Issued April 14, 2023
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
- 30548
- Date
- April 14, 2023
- Company
- Gilead Sciences Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Updates to the Product Monograph (PM) with long-term clinical efficacy and safety data; updates to the common name of the drug product on the mock-up labels.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BIKTARVY | Not yet assigned | — |
Medicinal ingredients
- EMTRICITABINE 200 MG per TAB
- BICTEGRAVIR SODIUM 50 MG per TAB
- TENOFOVIR ALAFENAMIDE HEMIFUMARATE 25 MG per TAB