TEVA-LEFLUNOMIDE 20 MG
LEFLUNOMIDE : 20 MG · DIN 02261278 · TEVA CANADA LIMITED
Health Canada status: MARKETED
What is TEVA-LEFLUNOMIDE?
TEVA-LEFLUNOMIDE 20 MG contains LEFLUNOMIDE : 20 MG. It is listed in the Health Canada Drug Product Database under DIN 02261278, held by TEVA CANADA LIMITED, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 14-Feb-2014. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is TEVA-LEFLUNOMIDE used for?
Treatment of active rheumatoid arthritis in adults.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02261278 |
|---|---|
| Brand name | TEVA-LEFLUNOMIDE |
| Generic / active ingredient | LEFLUNOMIDE : 20 MG |
| Manufacturer | TEVA CANADA LIMITED |
| Strength | 20 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | L04AK01 LEFLUNOMIDE |
| AHFS class | 90:24.04 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 14-Feb-2014 |
| Original market date | 2004-12-21 00:00:00 |
How is it administered?
Loading dose: 100 mg/day for 3 days. Maintenance: 20 mg/day (may reduce to 10 mg if not tolerated). Swallow whole with liquid, with or without food.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in the provided text snippet (refer to section 11 of full monograph).
How is it supplied?
White polyethylene bottles of 30 and 100 tablets.
Contraindications
Hypersensitivity to leflunomide/teriflunomide; immunodeficiency; impaired bone marrow function; serious infections; moderate-severe renal insufficiency; liver impairment; pregnancy; breastfeeding.
Warnings and precautions
Long half-life; risk of hepatotoxicity, hematotoxicity (pancytopenia), serious infections, colitis, and interstitial lung disease. Washout procedures may be required.
What can be used instead?
Other Canadian products sharing ATC code L04AK01 LEFLUNOMIDE. 18 of 33 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| ACCEL-LEFLUNOMIDE | 10 MG | TABLET | ACCEL PHARMA INC | MARKETED | DIN 02478862 |
| ACCEL-LEFLUNOMIDE | 20 MG | TABLET | ACCEL PHARMA INC | MARKETED | DIN 02478870 |
| APO-LEFLUNOMIDE | 10 MG | TABLET | APOTEX INC | MARKETED | DIN 02256495 |
| APO-LEFLUNOMIDE | 20 MG | TABLET | APOTEX INC | MARKETED | DIN 02256509 |
| ARAVA | 10 MG | TABLET | SANOFI-AVENTIS CANADA INC | MARKETED | DIN 02241888 |
| ARAVA | 20 MG | TABLET | SANOFI-AVENTIS CANADA INC | MARKETED | DIN 02241889 |
| LEFLUNOMIDE | 10 MG | TABLET | PRO DOC LIMITEE | MARKETED | DIN 02415828 |
| LEFLUNOMIDE | 10 MG | TABLET | SANIS HEALTH INC | MARKETED | DIN 02351668 |
| LEFLUNOMIDE | 10 MG | TABLET | SIVEM PHARMACEUTICALS ULC | MARKETED | DIN 02543575 |
| LEFLUNOMIDE | 20 MG | TABLET | SANIS HEALTH INC | MARKETED | DIN 02351676 |
Who else supplies LEFLUNOMIDE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. LEFLUNOMIDE appears in 28 registered pack listings across 6 markets, published on 5 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.