Approval · Notice of Compliance 14403 · 2013
CHAMPIX: Notice of Compliance 14403
Issued May 22, 2013
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
- 14403
- Date
- May 22, 2013
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Product Monograph update to align existing cardiovascular warnings in the Warnings and Precautions and Part III sections of the Product Monograph with the USPI and SmPC
- Therapeutic class
- Smoking cessation aid
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