Approval · Notice of Compliance 21155 · 2018
VIMOVO: Notice of Compliance 21155
Issued July 27, 2018
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
- 21155
- Date
- July 27, 2018
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To update the sponsor¿s labelling for the bottles from the current 3 panel label format to a 4 panel label format in addition, the sponsor is updating the contact information on the labels to align with the current health Canada standard
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