Approval · Notice of Compliance 8554 · 2007
NEXIUM: Notice of Compliance 8554
Issued January 23, 2007
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
- 8554
- Date
- January 23, 2007
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To introduce a new indication: for the treatment of pathological hypersecretory conditions, including zollinger-ellison syndrome
- Therapeutic class
- H+, k+-atpase inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| NEXIUM | Not yet assigned | — |
Medicinal ingredients
- ESOMEPRAZOLE MAGNESIUM TRIHYDRATE 20 MG per TAB
- ESOMEPRAZOLE MAGNESIUM TRIHYDRATE 40 MG per TAB