Approval · Notice of Compliance 25904 · 2021
BIKTARVY: Notice of Compliance 25904
Issued May 21, 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
- 25904
- Date
- May 21, 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 Product Monograph with the clinical safety and efficacy data from clinical trials in virologically suppressed HIV-1 infected geriatric patients (¿ 65 years of age) or adult patients with end stage renal disease (ESRD) on chronic hemodialysis
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