Approval · Notice of Compliance 20951 · 2018
ODEFSEY: Notice of Compliance 20951
Issued June 7, 2018
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
- 20951
- Date
- June 7, 2018
- Company
- Gilead Sciences Canada IncMississauga, Ontario, Canada
- Product type
- Nonprescription 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 ongoing Phase 3 clinical trials; to revise the lactic acidosis/severe hepatomegaly class warning; and to remove the lipodystrophy class warning
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ODEFSEY | Not yet assigned | — |
Medicinal ingredients
- EMTRICITABINE 200 MG per TAB
- RILPIVIRINE HYDROCHLORIDE 25 MG per TAB
- TENOFOVIR ALAFENAMIDE HEMIFUMARATE 25 MG per TAB