Approval · Notice of Compliance 28513 · 2022
NORITATE: Notice of Compliance 28513
Issued June 28, 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
- 28513
- Date
- June 28, 2022
- 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
- To update the Product Monograph (PM) with safety information regarding the risk of QT prolongation, particularly when metronidazole is administered with other QT prolonging drugs.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| NORITATE | Not yet assigned | — |
Medicinal ingredients
- METRONIDAZOLE 1 PER