Approval · Notice of Compliance 25638 · 2021
PREGABALIN: Notice of Compliance 25638
Issued April 8, 2021
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
- 25638
- Date
- April 8, 2021
- Company
- Sivem Pharmaceuticals UlcSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Licensing agreement between two companies
- Canadian reference product
- LYRICA (Pfizer Canada Ulc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PREGABALIN | 02403692 | Marketed |
| PREGABALIN | 02403706 | Marketed |
| PREGABALIN | 02403714 | Marketed |
| PREGABALIN | 02403722 | Marketed |
| PREGABALIN | 02403749 | Approved |
| PREGABALIN | 02403730 | Marketed |
Medicinal ingredients
- PREGABALIN 25 MG per CAP
- PREGABALIN 50 MG per CAP
- PREGABALIN 75 MG per CAP
- PREGABALIN 150 MG per CAP
- PREGABALIN 225 MG per CAP
- PREGABALIN 300 MG per CAP