Approval · Notice of Compliance 28128 · 2022
FLAGYSTATIN: Notice of Compliance 28128
Issued May 10, 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
- 28128
- Date
- May 10, 2022
- Company
- Sanofi-Aventis Canada Inc.Toronto, Ontario, 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 interference of metronidazole with certain laboratory tests and the risk of QT prolongation, particularly when metronidazole is administered with other QT prolonging drugs
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLAGYSTATIN | Not yet assigned | — |
Medicinal ingredients
- METRONIDAZOLE 500 MG per OVULE
- NYSTATIN 100,000 UNIT per OVULE