Approval · Notice of Compliance 33911 · 2024
PRECEDEX: Notice of Compliance 33911
Issued August 30, 2024
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
- 33911
- Date
- August 30, 2024
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the Product Monograph with new safety information. Update to Patient Medication Information. Update to Package Insert
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