Approval · Notice of Compliance 27934 · 2022
PRECEDEX: Notice of Compliance 27934
Issued April 7, 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
- 27934
- Date
- April 7, 2022
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update the Product Monograph to the 2020 PM format. Remove the Special Handling Instructions from the Product Monograph and Package Insert and updates to the package labels.
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