Approval · Notice of Compliance 28010 · 2022
VIMOVO: Notice of Compliance 28010
Issued April 22, 2022
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
- 28010
- Date
- April 22, 2022
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To add safety information to the Product Monograph (PM) in response to a class labelling Advisement Letter dated June 09, 2021 regarding the use of nonsteroidal anti-inflammatory drugs (NSAIDs) during pregnancy.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| VIMOVO | Not yet assigned | — |
Medicinal ingredients
- NAPROXEN 375 MG per TAB
- ESOMEPRAZOLE 20 MG per TAB
- NAPROXEN 500 MG per TAB