Approval · Notice of Compliance 19029 · 2017
CHAMPIX: Notice of Compliance 19029
Issued February 21, 2017
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
- 19029
- Date
- February 21, 2017
- 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 safety information regarding neuropsychiatric adverse reaction associated with champix
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CHAMPIX | Not yet assigned | — |
Medicinal ingredients
- VARENICLINE TARTRATE 0.5 MG per TAB
- VARENICLINE TARTRATE 1 MG per TAB