Approval · Notice of Compliance 13321 · 2012
SUMATRIPTAN DF: Notice of Compliance 13321
Issued May 31, 2012
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
- 13321
- Date
- May 31, 2012
- Company
- Sivem Pharmaceuticals UlcSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- New manufacturer and product name
- Therapeutic class
- 5-HT1 Receptor Agonist; Migraine Therapy
- Canadian reference product
- IMITREX DF (Glaxosmithkline Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SUMATRIPTAN DF | 02385562 | Approved |
| SUMATRIPTAN DF | 02385570 | Marketed |
| SUMATRIPTAN DF | 02385589 | Marketed |
Medicinal ingredients
- SUMATRIPTAN SUCCINATE 25 MG per TAB
- SUMATRIPTAN SUCCINATE 50 MG per TAB
- SUMATRIPTAN SUCCINATE 100 MG per TAB