Approval · Notice of Compliance 7130 · 2005
ALERTEC: Notice of Compliance 7130
Issued June 23, 2005
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
- 7130
- Date
- June 23, 2005
- Company
- Shire Biochem Inc.Saint Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication as an adjunct for excessive daytime sleepiness due to sleep apnea
- Therapeutic class
- Central nervous system stimulant
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ALERTEC | Not yet assigned | — |
Medicinal ingredients
- MODAFINIL 100 MG per TAB