TRACLEER 62.5 MG
BOSENTAN (BOSENTAN MONOHYDRATE) : 62.5 MG · DIN 02244981 · JANSSEN INC
Health Canada status: MARKETED
What is TRACLEER?
TRACLEER 62.5 MG contains BOSENTAN (BOSENTAN MONOHYDRATE) : 62.5 MG. It is listed in the Health Canada Drug Product Database under DIN 02244981, held by JANSSEN INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 20-Feb-2020. 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 TRACLEER used for?
TRACLEER ® (bosentan monohydrate) is indicated for the treatment of pulmonary arterial hypertension in patients with WHO functional class III or IV primary pulmonary hypertension, or pulmonary hypertension secondary to scleroderma or congenital heart disease or human immunodeficiency virus in patients who did not respond adequately to conventional therapy. A prolongation of time to clinical worsening was also shown in patients with WHO functional class II.
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 | 02244981 |
|---|---|
| Brand name | TRACLEER |
| Generic / active ingredient | BOSENTAN (BOSENTAN MONOHYDRATE) : 62.5 MG |
| Manufacturer | JANSSEN INC |
| Strength | 62.5 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | C02KX01 BOSENTAN |
| AHFS class | 48:48.12 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 20-Feb-2020 |
| Original market date | 2001-12-14 00:00:00 |
How is it stored and handled?
null
How is it supplied?
62.5 mg film - coated, round, biconvex, orange - white tablets debossed with '62,5' on one side in carton box containing 4 blisters of 14 tablets each (56 tablets in total). • 125 mg film - coated, oval, biconvex, orange - white tablets debossed with '125' on one side in carton box containing 4 blisters of 14 tablets each (56 tablets in total).
What can be used instead?
Other Canadian products sharing ATC code C02KX01 BOSENTAN. 6 of 32 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 |
|---|---|---|---|---|---|
| PMS-BOSENTAN | 125 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02383020 |
| PMS-BOSENTAN | 62.5 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02383012 |
| TARO-BOSENTAN | 125 MG | TABLET | TARO PHARMACEUTICALS INC | MARKETED | DIN 02483149 |
| TARO-BOSENTAN | 62.5 MG | TABLET | TARO PHARMACEUTICALS INC | MARKETED | DIN 02483130 |
| TRACLEER | 125 MG | TABLET | JANSSEN INC | MARKETED | DIN 02244982 |
| ACCEL-BOSENTAN | 125 MG | TABLET | ACCEL PHARMA INC | CANCELLED PRE MARKET | DIN 02435403 |
| ACT BOSENTAN | 125 MG | TABLET | ACTAVIS PHARMA COMPANY | CANCELLED POST MARKET | DIN 02386208 |
| ACT BOSENTAN | 62.5 MG | TABLET | ACTAVIS PHARMA COMPANY | CANCELLED POST MARKET | DIN 02386194 |
| ALEMBIC-BOSENTAN | 125 MG | TABLET | ALEMBIC PHARMACEUTICALS LIMITED | APPROVED | DIN 02423065 |
| ALEMBIC-BOSENTAN | 62.5 MG | TABLET | ALEMBIC PHARMACEUTICALS LIMITED | APPROVED | DIN 02423057 |
Who else supplies BOSENTAN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. BOSENTAN appears in 262 registered pack listings across 13 markets, published on 11 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.