Approval · Notice of Compliance 32185 · 2023
CABENUVA: Notice of Compliance 32185
Issued November 23, 2023
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
- 32185
- Date
- November 23, 2023
- Company
- Viiv Healthcare UlcMontreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the Product Monograph (PM) with post-market adverse reactions of suicide attempt and suicidal ideation; revision to special handling instructions for Cabenuva in the PM, outer label and instructions for use (IFU); and update to the IFU for Cabenuva.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CABENUVA | Not yet assigned | — |
| CABENUVA | 02497220 | Marketed |
| VOCABRIA | Not yet assigned | — |
Medicinal ingredients
- CABOTEGRAVIR 200 MG per ML
- RILPIVIRINE 300 MG per ML
- CABOTEGRAVIR SODIUM 30 MG per TAB