LEFLUNOMIDE DIN 02543575
Health Canada record
| Active ingredient(s) | LEFLUNOMIDE 10 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L04AK01 LEFLUNOMIDE |
| Original market date | 03-Jun-2024 |
| Current status date | 03-Jun-2024 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sivem Pharmaceuticals ULC — licence 101965, currently licensed, last inspection rating C (2025-02-04).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing LEFLUNOMIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02478870 | ACCEL-LEFLUNOMIDE | ACCEL PHARMA INC | Tablet | LEFLUNOMIDE 20 MG | Marketed |
| 02478862 | ACCEL-LEFLUNOMIDE | ACCEL PHARMA INC | Tablet | LEFLUNOMIDE 10 MG | Marketed |
| 02256495 | APO-LEFLUNOMIDE | APOTEX INC | Tablet | LEFLUNOMIDE 10 MG | Marketed |
| 02256509 | APO-LEFLUNOMIDE | APOTEX INC | Tablet | LEFLUNOMIDE 20 MG | Marketed |
| 02241888 | ARAVA | SANOFI-AVENTIS CANADA INC | Tablet | LEFLUNOMIDE 10 MG | Marketed |
| 02241889 | ARAVA | SANOFI-AVENTIS CANADA INC | Tablet | LEFLUNOMIDE 20 MG | Marketed |
| 02351676 | LEFLUNOMIDE | SANIS HEALTH INC | Tablet | LEFLUNOMIDE 20 MG | Marketed |
| 02543583 | LEFLUNOMIDE | SIVEM PHARMACEUTICALS ULC | Tablet | LEFLUNOMIDE 20 MG | Marketed |
| 02351668 | LEFLUNOMIDE | SANIS HEALTH INC | Tablet | LEFLUNOMIDE 10 MG | Marketed |
| 02551926 | MAR-LEFLUNOMIDE | MARCAN PHARMACEUTICALS INC | Tablet | LEFLUNOMIDE 20 MG | Marketed |
| 02551918 | MAR-LEFLUNOMIDE | MARCAN PHARMACEUTICALS INC | Tablet | LEFLUNOMIDE 10 MG | Marketed |
| 02465876 | ODAN-LEFLUNOMIDE | ODAN LABORATORIESLTD | Tablet | LEFLUNOMIDE 20 MG | Approved |
| 02465868 | ODAN-LEFLUNOMIDE | ODAN LABORATORIESLTD | Tablet | LEFLUNOMIDE 10 MG | Approved |
| 02415828 | PRO-LEFLUNOMIDE | PRO DOC LIMITEE | Tablet | LEFLUNOMIDE 10 MG | Marketed |
| 02415836 | PRO-LEFLUNOMIDE | PRO DOC LIMITEE | Tablet | LEFLUNOMIDE 20 MG | Marketed |
| 02283972 | SANDOZ LEFLUNOMIDE | SANDOZ CANADA INCORPORATED | Tablet | LEFLUNOMIDE 20 MG | Marketed |
| 02283964 | SANDOZ LEFLUNOMIDE | SANDOZ CANADA INCORPORATED | Tablet | LEFLUNOMIDE 10 MG | Marketed |
| 02261278 | TEVA-LEFLUNOMIDE | TEVA CANADA LIMITED | Tablet | LEFLUNOMIDE 20 MG | Marketed |
| 02261251 | TEVA-LEFLUNOMIDE | TEVA CANADA LIMITED | Tablet | LEFLUNOMIDE 10 MG | Marketed |
| 02241890 | ARAVA | SANOFI-AVENTIS CANADA INC | Tablet | LEFLUNOMIDE 100 MG | Cancelled Post Market |
| 02309343 | DOM-LEFLUNOMIDE | DOMINION PHARMACAL | Tablet | LEFLUNOMIDE 10 MG | Cancelled Pre Market |
| 02309351 | DOM-LEFLUNOMIDE | DOMINION PHARMACAL | Tablet | LEFLUNOMIDE 20 MG | Cancelled Pre Market |
| 02319225 | MYLAN-LEFLUNOMIDE | MYLAN PHARMACEUTICALS ULC | Tablet | LEFLUNOMIDE 10 MG | Cancelled Post Market |
| 02319233 | MYLAN-LEFLUNOMIDE | MYLAN PHARMACEUTICALS ULC | Tablet | LEFLUNOMIDE 20 MG | Cancelled Post Market |
| 02346354 | NTP-LEFLUNOMIDE | TEVA CANADA LIMITED | Tablet | LEFLUNOMIDE 20 MG | Cancelled Pre Market |
| 02346346 | NTP-LEFLUNOMIDE | TEVA CANADA LIMITED | Tablet | LEFLUNOMIDE 10 MG | Cancelled Pre Market |
| 02336138 | NU-LEFLUNOMIDE | NU-PHARM INC | Tablet | LEFLUNOMIDE 10 MG | Cancelled (Unreturned Annual) |
| 02336146 | NU-LEFLUNOMIDE | NU-PHARM INC | Tablet | LEFLUNOMIDE 20 MG | Cancelled (Unreturned Annual) |
| 02309335 | PHL-LEFLUNOMIDE | PHARMEL INC | Tablet | LEFLUNOMIDE 20 MG | Cancelled Post Market |
| 02309327 | PHL-LEFLUNOMIDE | PHARMEL INC | Tablet | LEFLUNOMIDE 10 MG | Cancelled Post Market |
| 02288273 | PMS-LEFLUNOMIDE | PHARMASCIENCE INC | Tablet | LEFLUNOMIDE 20 MG | Dormant |
| 02288265 | PMS-LEFLUNOMIDE | PHARMASCIENCE INC | Tablet | LEFLUNOMIDE 10 MG | Dormant |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 32223 | 2023-11-30 | Abbreviated New Drug Submission (ANDS) | Administrative: Licensing Agreement Between Two Manufacturers |
International API supply for LEFLUNOMIDE
5 valid EDQM Certificates of Suitability from 5 holders. 7 active FDA Drug Master Files.
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