Approval · Notice of Compliance 9458 · 2008
CIPRALEX: Notice of Compliance 9458
Issued March 31, 2008
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
- 9458
- Date
- March 31, 2008
- Company
- Lundbeck Canada IncSt-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: maintenance of efficacy in generalized anxiety disorder for up to 6 months
- Therapeutic class
- Antidepressant / anxiolytic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CIPRALEX | Not yet assigned | — |
Medicinal ingredients
- ESCITALOPRAM OXALATE 5 MG per TAB
- ESCITALOPRAM OXALATE 10 MG per TAB
- ESCITALOPRAM OXALATE 15 MG per TAB
- ESCITALOPRAM OXALATE 20 MG per TAB