Approval · Notice of Compliance 30421 · 2023
PRECEDEX: Notice of Compliance 30421
Issued March 30, 2023
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
- 30421
- Date
- March 30, 2023
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Safety Update and Updates to the Label for the small 2 ml vial
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PRECEDEX | Not yet assigned | — |
Medicinal ingredients
- DEXMEDETOMIDINE HYDROCHLORIDE 100 MCG per ML
- DEXMEDETOMIDINE HYDROCHLORIDE 4 MCG per ML