Approval · Notice of Compliance 30518 · 2023
VYVANSE: Notice of Compliance 30518
Issued April 14, 2023
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
- 30518
- Date
- April 14, 2023
- Company
- Takeda Canada IncorporatedToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Safety Updates to the Product Monograph (PM) Update the Clinical Trial section to add demographics table for 3 pivotal BED studies. Migrate PM to the 2020 Master Template.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| VYVANSE | Not yet assigned | — |
Medicinal ingredients
- LISDEXAMFETAMINE DIMESYLATE 10 MG per CAP
- 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
- LISDEXAMFETAMINE DIMESYLATE 70 MG per CAP
- LISDEXAMFETAMINE DIMESYLATE 10 MG per TAB
- LISDEXAMFETAMINE DIMESYLATE 20 MG per TAB
- LISDEXAMFETAMINE DIMESYLATE 30 MG per TAB
- LISDEXAMFETAMINE DIMESYLATE 40 MG per TAB
- LISDEXAMFETAMINE DIMESYLATE 50 MG per TAB
- LISDEXAMFETAMINE DIMESYLATE 60 MG per TAB