Approval · Notice of Compliance 14285 · 2013
VYVANSE: Notice of Compliance 14285
Issued April 11, 2013
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
- 14285
- Date
- April 11, 2013
- Company
- Shire Canada IncLaval, QC, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of an indication in a combined population of children and adolescents
- Therapeutic class
- Central nervous system stimulant for attention deficit hyperactivity disorder
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| VYVANSE | Not yet assigned | — |
Medicinal ingredients
- LISDEXAMFETAMINE DIMESYLATE 20 MG per CAP
- LISDEXAMFETAMINE DIMESYLATE 30 MG per CAP
- LISDEXAMFETAMINE DIMESYLATE 40 MG per CAP
- LISDEXAMFETAMINE DIMESYLATE 50 MG per CAP
- LISDEXAMFETAMINE DIMESYLATE 60 MG per CAP