Approval · Notice of Compliance 18747 · 2016
LOSEC: Notice of Compliance 18747
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
- 18747
- 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 this supplemental new drug submission is to update the labelling of losec with safety information with respoct to interaction with antiretroviral products in response to health canada's advisement letter for all proton pump inhibitors
Products in this notice
Medicinal ingredients
- OMEPRAZOLE MAGNESIUM 10 MG per TAB
- OMEPRAZOLE MAGNESIUM 20 MG per TAB
- OMEPRAZOLE 20 MG per CAP