Approval · Notice of Compliance 16327 · 2014
CHAMPIX: Notice of Compliance 16327
Issued November 20, 2014
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
- 16327
- Date
- November 20, 2014
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Description of two new studies in the action and clinical pharmacology section of the product monograph
- Therapeutic class
- Smoking sessation aid
Products in this notice
Medicinal ingredients
- VARENICLINE TARTRATE 1 MG per TAB
- VARENICLINE TARTRATE 0.5 MG per TAB