Approval · Notice of Compliance 36400 · 2025
ROFACT: Notice of Compliance 36400
Issued November 18, 2025
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
- 36400
- Date
- November 18, 2025
- Company
- Bausch Health, Canada Inc.Laval, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a manufacturing site and/or manufacturer involving production of the drug substance
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ROFACT | Not yet assigned | — |