Approval · Notice of Compliance 28780 · 2022
PREZCOBIX: Notice of Compliance 28780
Issued August 17, 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
- 28780
- Date
- August 17, 2022
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Safety updates to the Product Monograph with respect to a drug-drug interaction (DDI) with dabigatran and to remove the paper package insert from the final packaging.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PREZCOBIX | Not yet assigned | — |
Medicinal ingredients
- DARUNAVIR ETHANOLATE 800 MG per TAB
- COBICISTAT 150 MG per TAB