Approval · Notice of Compliance 30909 · 2023
SUMATRIPTAN DF: Notice of Compliance 30909
Issued June 1, 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
- 30909
- Date
- June 1, 2023
- Company
- Sivem Pharmaceuticals UlcSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Labelling Only
- Reason
- Administrative: Licensing Agreement Between Two Manufacturers. Update to the Product Monograph and Package Insert
- Canadian reference product
- IMITREX DF
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SUMATRIPTAN DF | 02385589 | Marketed |
| SUMATRIPTAN DF | 02385562 | Approved |
| SUMATRIPTAN DF | 02385570 | Marketed |
Medicinal ingredients
- SUMATRIPTAN SUCCINATE 100 MG per TAB
- SUMATRIPTAN SUCCINATE 25 MG per TAB
- SUMATRIPTAN SUCCINATE 50 MG per TAB