Approval · Notice of Compliance 22831 · 2019
ODEFSEY: Notice of Compliance 22831
Issued October 25, 2019
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
- 22831
- Date
- October 25, 2019
- 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 long term safety and efficacy data from the clinical trials in human immunodeficiency virus (HIV)-1 infected treatment-naïve adult patients and virologically suppressed adult patients with mild to moderate renal impairment
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ODEFSEY | Not yet assigned | — |
Medicinal ingredients
- EMTRICITABINE 200 MG per TAB
- TENOFOVIR ALAFENAMIDE 25 MG per TAB
- RILPIVIRINE 25 MG per TAB