PRADAXA 150 MG
DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) : 150 MG · DIN 02358808 · BOEHRINGER INGELHEIM (CANADA) LTD LTEE
Health Canada status: MARKETED
What is PRADAXA?
PRADAXA 150 MG contains DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) : 150 MG. It is listed in the Health Canada Drug Product Database under DIN 02358808, held by BOEHRINGER INGELHEIM (CANADA) LTD LTEE, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 28-Mar-2013. 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 PRADAXA used for?
Prevention of VTE in elective THR or TKR surgery; treatment and prevention of recurrent DVT and PE; prevention of stroke and systemic embolism in patients with atrial fibrillation.
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 | 02358808 |
|---|---|
| Brand name | PRADAXA |
| Generic / active ingredient | DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) : 150 MG |
| Manufacturer | BOEHRINGER INGELHEIM (CANADA) LTD LTEE |
| Strength | 150 MG |
| Dosage form | CAPSULE |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | B01AE07 DABIGATRAN ETEXILATE |
| AHFS class | 20:12.04.12 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 28-Mar-2013 |
| Original market date | 2010-11-03 00:00:00 |
How is it administered?
VTE prevention (THR/TKR): 110-220 mg QD. AF/VTE treatment: 150 mg BID. Adjust for elderly or moderate renal impairment. Swallow whole with water, with or without food. Do not open capsules.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not specified in the provided text snippet (refer to Part I Summary or Storage and Stability section 39).
How is it supplied?
Not explicitly detailed in the provided text (mentions 'component of the container' and 'bottles' or 'blisters' are standard but not specified in this snippet).
Contraindications
Severe renal impairment (eCrCl < 30mL/min); active clinically significant bleeding; lesions at risk of bleeding; strong P-gp inhibitors (oral ketoconazole, glecaprevir/pibrentasvir); other anticoagulants; prosthetic heart valves.
Warnings and precautions
Premature discontinuation increases thrombotic risk. Increased risk of bleeding; use caution with P-gp inhibitors or antiplatelets. Risk of spinal/epidural hematoma with spinal procedures.
What can be used instead?
Other Canadian products sharing ATC code B01AE07 DABIGATRAN ETEXILATE. 5 of 8 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 |
|---|---|---|---|---|---|
| APO-DABIGATRAN | 110 MG | CAPSULE | APOTEX INC | MARKETED | DIN 02468905 |
| APO-DABIGATRAN | 150 MG | CAPSULE | APOTEX INC | MARKETED | DIN 02468913 |
| APO-DABIGATRAN | 75 MG | CAPSULE | APOTEX INC | MARKETED | DIN 02468891 |
| PRADAXA | 110 MG | CAPSULE | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | MARKETED | DIN 02312441 |
| PRADAXA | 75 MG | CAPSULE | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | CANCELLED POST MARKET | DIN 02312433 |
| TEVA-DABIGATRAN | 150 MG | CAPSULE | TEVA CANADA LIMITED | CANCELLED PRE MARKET | DIN 02463466 |
| TEVA-DABIGATRAN | 75 MG | CAPSULE | TEVA CANADA LIMITED | CANCELLED PRE MARKET | DIN 02463458 |
Who else supplies DABIGATRAN ETEXILATE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. DABIGATRAN ETEXILATE appears in 448 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.