Approval · Notice of Compliance 24337 · 2020
DOVATO: Notice of Compliance 24337
Issued September 30, 2020
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
- 24337
- Date
- September 30, 2020
- Company
- Viiv Healthcare UlcMontreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To update the product monograph with week 96 safety and efficacy data from ongoing phase 3 studies in treatment-naive HIV-1 infected patients and with 48 week data from phase 3 study in virologically suppressed HIV-1 infected patients
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DOVATO | Not yet assigned | — |
Medicinal ingredients
- LAMIVUDINE 300 MG per TAB
- DOLUTEGRAVIR 50 MG per TAB