Approval · Notice of Compliance 3110 · 1998
LOSEC: Notice of Compliance 3110
Issued March 23, 1998
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
- 3110
- Date
- March 23, 1998
- Company
- Astra Pharma Inc.Mississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Provides for new indication: losec in combination with two antimicrobrials to treat peptic ulcer disease by eradicating H. pylori
- Therapeutic class
- H+, K+-atpase inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LOSEC | Not yet assigned | — |
Medicinal ingredients
- OMEPRAZOLE MAGNESIUM 20 MG per TAB