Approval · Notice of Compliance 16612 · 2015
VIMOVO: Notice of Compliance 16612
Issued February 11, 2015
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
- 16612
- Date
- February 11, 2015
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the safety information in the product monograph related to nsaid's induced adverse effects on female fertility
- Therapeutic class
- Nsaid and h+,k+-atpse inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| VIMOVO | Not yet assigned | — |
Medicinal ingredients
- NAPROXEN 375 MG per TAB
- ESOMEPRAZOLE MAGNESIUM TRIHYDRATE 20 MG per TAB
- NAPROXEN 500 MG per TAB