Approval · Notice of Compliance 29680 · 2022
CABENUVA: Notice of Compliance 29680
Issued December 9, 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
- 29680
- Date
- December 9, 2022
- Company
- Viiv Healthcare UlcMontreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Expansion of indication to adolescent patients (at least 12 years of age and weighing at least 35 kg) and long-term safety and efficacy updates in the Product Monograph (PM)
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