MYLAN-LEFLUNOMIDE Strength
Active ingredient(s) See footnote 8 : Strength LEFLUNOMIDE : 20 MG · DIN 02319233 · MYLAN PHARMACEUTICALS ULC 85 Advance Road Etobicoke Ontario Canada M8Z 2S6
Health Canada status: CANCELLED POST MARKET
What is MYLAN-LEFLUNOMIDE?
MYLAN-LEFLUNOMIDE Strength contains Active ingredient(s) See footnote 8 : Strength LEFLUNOMIDE : 20 MG. It is listed in the Health Canada Drug Product Database under DIN 02319233, held by MYLAN PHARMACEUTICALS ULC 85 Advance Road Etobicoke Ontario Canada M8Z 2S6, supplied as Tablet for Oral administration. Health Canada currently lists it as cancelled post market, status dated 09-Jan-2017. 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 MYLAN-LEFLUNOMIDE used for?
Indicated in adults for the treatment of active rheumatoid arthritis.
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 | 02319233 |
|---|---|
| Brand name | MYLAN-LEFLUNOMIDE |
| Generic / active ingredient | Active ingredient(s) See footnote 8 : Strength LEFLUNOMIDE : 20 MG |
| Manufacturer | MYLAN PHARMACEUTICALS ULC 85 Advance Road Etobicoke Ontario Canada M8Z 2S6 |
| Strength | Strength |
| Dosage form | Tablet |
| Route of administration | Oral |
| Schedule | PRESCRIPTION |
| ATC code | L04AK01 LEFLUNOMIDE |
| Biosimilar | No |
| Health Canada status | CANCELLED POST MARKET |
| Status date | 09-Jan-2017 |
| Original market date | 2008-11-14 |
How is it administered?
Treatment starts with a loading dose of 100 mg daily for 3 days, followed by a maintenance dose of 10 mg to 20 mg once daily.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (standard section header present but content truncated).
How is it supplied?
Not explicitly detailed in provided text (mentions 10 mg and 20 mg strengths).
Contraindications
Hypersensitivity to leflunomide/teriflunomide; immunodeficiency; impaired bone marrow function; serious infections; moderate to severe renal/liver impairment; pregnancy/breastfeeding; age <18.
Warnings and precautions
Long half-life; risk of hepatotoxicity, hematotoxicity (pancytopenia), interstitial lung disease, peripheral neuropathy, and serious skin reactions (SJS/TEN). Washout procedure 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 | SIVEM PHARMACEUTICALS ULC | MARKETED | DIN 02543575 |
| LEFLUNOMIDE | 10 MG | TABLET | SANIS HEALTH INC | MARKETED | DIN 02351668 |
| 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.