Approval · Notice of Compliance 28409 · 2022
CABENUVA: Notice of Compliance 28409
Issued June 15, 2022
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
- 28409
- Date
- June 15, 2022
- 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 Product Monograph (PM) with long-term efficacy and safety data, leading to changes in the dosing recommendations. PM was also converted to the 2020 format.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CABENUVA | Not yet assigned | — |
| VOCABRIA | Not yet assigned | — |
Medicinal ingredients
- CABOTEGRAVIR 400 MG per 2ML
- RILPIVIRINE 600 MG per 2ML
- CABOTEGRAVIR 600 MG per 3ML
- RILPIVIRINE 900 MG per 3ML
- CABOTEGRAVIR SODIUM 30 MG per TAB