Approval · Notice of Compliance 14944 · 2013
LEFLUNOMIDE: Notice of Compliance 14944
Issued November 26, 2013
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
- 14944
- Date
- November 26, 2013
- Company
- Pro Doc LimiteeLaval, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Licensing agreement between two companies
- Therapeutic class
- Antirheumatic; immunomodulator agent
- Canadian reference product
- ARAVA (Aventis Pharma Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LEFLUNOMIDE | 02415828 | Marketed |
| LEFLUNOMIDE | 02415836 | Marketed |
Medicinal ingredients
- LEFLUNOMIDE 10 MG per TAB
- LEFLUNOMIDE 20 MG per TAB