Approval · Notice of Compliance 15807 · 2014
LEFLUNOMIDE: Notice of Compliance 15807
Issued July 11, 2014
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
- 15807
- Date
- July 11, 2014
- Company
- Sanis Health Inc.Brampton, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Licensing agreement between two companies
- Therapeutic class
- Anti-rheumatic, immunomodulator agent
- Canadian reference product
- ARAVA (Aventis Pharma Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LEFLUNOMIDE | 02351668 | Marketed |
| LEFLUNOMIDE | 02351676 | Marketed |
Medicinal ingredients
- LEFLUNOMIDE 10 MG per TAB
- LEFLUNOMIDE 20 MG per TAB