Approval · Notice of Compliance 21342 · 2018
PRECEDEX: Notice of Compliance 21342
Issued September 25, 2018
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
- 21342
- Date
- September 25, 2018
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update 4 mcg / mL vial and carton labels to comply with PLL requirements
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PRECEDEX | Not yet assigned | — |
Medicinal ingredients
- DEXMEDETOMIDINE HYDROCHLORIDE 4 MCG per ML