Approval · Notice of Compliance 22134 · 2019
CHAMPIX: Notice of Compliance 22134
Issued May 7, 2019
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
- 22134
- Date
- May 7, 2019
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Labelling Only
- Reason
- Update of package insert, inner bottle and carton labels for the 0.5 mg strength
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CHAMPIX | Not yet assigned | — |
Medicinal ingredients
- VARENICLINE TARTRATE 0.5 MG per TAB