Approval · Notice of Compliance 18545 · 2016
VYVANSE: Notice of Compliance 18545
Issued September 30, 2016
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
- 18545
- Date
- September 30, 2016
- Company
- Shire Pharma Canada UlcToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New 70 mg strength for the treatment of binge eating disorder in adults. new indication for the 30, 50, 70 mg strengths for the treatment of binge eating disorder in adults
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| VYVANSE | Not yet assigned | — |
| VYVANSE | 02458071 | Marketed |
Medicinal ingredients
- LISDEXAMFETAMINE DIMESYLATE 30 MG per CAP
- LISDEXAMFETAMINE DIMESYLATE 50 MG per CAP
- LISDEXAMFETAMINE DIMESYLATE 70 MG per CAP