THROMBATE III 500 UNIT — DIN 02189135
ANTITHROMBIN III (HUMAN) : 500 UNIT · GRIFOLS THERAPEUTICS LLC · POWDER FOR SOLUTION · wholesale supply in Canada
Health Canada status: APPROVED
What is THROMBATE III?
THROMBATE III 500 UNIT contains ANTITHROMBIN III (HUMAN) : 500 UNIT. It is listed in the Health Canada Drug Product Database under DIN 02189135, held by GRIFOLS THERAPEUTICS LLC, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as approved, status dated 30-Jan-2012. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A). This DIN is not currently being marketed in Canada, so it is sourced to order where a compliant route exists rather than held in stock.
What is THROMBATE III used for?
THROMBATE III ® is indicated for the treatment of patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism. Subjects with ATIII deficiency should be informed about the risk of thrombosis in connection with pregnancy and surgery and about the inheritance of the disease.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Is there a generic Antithrombin in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
4 holders have a Canadian DIN containing Antithrombin, across 7 DINs, of which 2 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| TAKEDA CANADA INC | 2 | 2 | ANTITHROMBIN III NF | Sourceable in Canada |
| GRIFOLS THERAPEUTICS LLC | 2 | 0 | THROMBATE III | No marketed DIN |
| MILES INC. - PHARMACEUTICAL DIVISION | 2 | 0 | THROMBATE III PWS IV 1000IU/VIAL, THROMBATE III PWS IV 500IU/VIAL | No marketed DIN |
| BAXTER AG | 1 | 0 | ANTITHROMBIN III IMMUNO | No marketed DIN |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 500 UNIT |
|---|---|
| Dosage form | POWDER FOR SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | Single dose vials with 500 IU, 10 mL Sterile Water for Injection, USP, sterile double ended transfer needle and sterile filter needle. |
| Storage | Store at a temperature not to exceed 25°C. Freezing should be avoided. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Antithrombin |
|---|---|
| ATC code | B01AB02 |
| AHFS class | 20:12.04.12 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02189135 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2189135 |
| Brand name | THROMBATE III |
| Generic / active ingredient | ANTITHROMBIN III (HUMAN) : 500 UNIT |
| Market authorization holder | GRIFOLS THERAPEUTICS LLC |
| Health Canada schedule | Schedule D |
| ATC code | B01AB02 |
| ATC anatomical main group | B — Blood and blood-forming organs |
| ATC therapeutic subgroup | B01AB |
| Current status | APPROVED |
| Status date | 30-Jan-2012 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
2 of 7 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ANTITHROMBIN III NF | 1100 UNIT | KIT ; POWDER FOR SOLUTION | TAKEDA CANADA INC | MARKETED | 02237810 |
| ANTITHROMBIN III NF | 550 UNIT | POWDER FOR SOLUTION ; KIT | TAKEDA CANADA INC | MARKETED | 02237811 |
| ANTITHROMBIN III IMMUNO | 30 ML | POWDER FOR SOLUTION | BAXTER AG | CANCELLED POST MARKET | 02237812 |
| THROMBATE III | 1000 UNIT | POWDER FOR SOLUTION | GRIFOLS THERAPEUTICS LLC | CANCELLED POST MARKET | 02189143 |
| THROMBATE III PWS IV 1000IU/VIAL | 1000 UNIT | POWDER FOR SOLUTION | MILES INC. - PHARMACEUTICAL DIVISION | CANCELLED POST MARKET | 02020572 |
| THROMBATE III PWS IV 500IU/VIAL | 500 UNIT | POWDER FOR SOLUTION | MILES INC. - PHARMACEUTICAL DIVISION | CANCELLED POST MARKET | 02020580 |
2 · Same class — other molecules in ATC B01AB
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Enoxaparin | AXBERI · AXBERI HP · ELONOX · ELONOX HP · +9 more | 46 | 44 | Yes |
| Tinzaparin | INNOHEP · INNOHEP DISP.SYR.-11700 ANTI-XA IU/ML · LOGIPARIN LIQ SC 10000 FXAIU/ML | 13 | 11 | Yes |
| Heparin | CALCILEAN INJ 20000UNIT/0.8ML · CALCIPARINE INJ 20000IU/AMP · CALCIPARINE INJ 5000IU · HEPALEAN 10,000 USP · +17 more | 32 | 10 | Yes |
| Dalteparin | FRAGMIN · FRAGMIN INJ.-LIQ 2500 IU(ANTI-XA)/ML | 13 | 10 | Yes |
| Heparin, Combinations | HEPARIN SOD AND 0.9% SOD CHLORIDE INJ · HEPARIN SODIUM & 5% DEXTROSE INJECTION LIQ · HEPARIN SODIUM & DEXTROSE 5% IN VIAFLEX LIQ · HEPARIN SODIUM 20000UNITS IN 5% DEXTROSE INJ · +4 more | 8 | 4 | Yes |
| Antithrombin | ANTITHROMBIN III IMMUNO · ANTITHROMBIN III NF · THROMBATE III · THROMBATE III PWS IV 1000IU/VIAL · +1 more | 7 | 2 | Yes |
| Danaparoid | ORGARAN | 1 | 1 | Yes |
| Nadroparin | FRAXIPARINE · FRAXIPARINE FORTE | 8 | 0 | Not in Canada |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC B01A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| B01AF | Apixaban · Edoxaban · Rivaroxaban | 159 | 121 |
| B01AC | Abciximab · Acetylsalicylic Acid · Cangrelor · Clopidogrel · Combinations · +10 more | 158 | 66 |
| B01AA | Acenocoumarol · Warfarin | 62 | 16 |
| B01AE | Argatroban · Bivalirudin · Dabigatran Etexilate · Lepirudin | 18 | 11 |
| B01AX | Caplacizumab · Defibrotide · Fondaparinux | 10 | 5 |
| B01AD | Alteplase · Ancrod · Anistreplase · Drotrecogin Alfa · Reteplase · +3 more | 22 | 4 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
How can I get it?
This product is approved by Health Canada but not yet marketed in Canada, so there is no Canadian supply to draw on today. Nexara can tell you whether it has been launched, and can look at supply from other markets where a Canadian pack is not required or where importation is 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. Patients and unlicensed buyers are routed to a partner pharmacy.
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.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
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.