Approval · Notice of Compliance 18749 · 2016
VIMOVO: Notice of Compliance 18749
Issued November 14, 2016
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
- 18749
- Date
- November 14, 2016
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- This purpose of tis supplemental new drug submission is to update tyhe labelling of vimovo with safety information with respect to interaction with antiretroviral products ;in response to health canada's advisement letter for all proton-pump inhibitors
Products in this notice
Medicinal ingredients
- NAPROXEN 375 MG per TAB
- ESOMEPRAZOLE MAGNESIUM TRIHYDRATE 20 MG per MG
- NAPROXEN 500 MG per TAB
- ESOMEPRAZOLE MAGNESIUM TRIHYDRATE 20 MG per TAB