REBINYN 3000 UNIT — DIN 02532964
COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED : 3000 UNIT · NOVO NORDISK CANADA INC · POWDER FOR SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is REBINYN?
REBINYN 3000 UNIT contains COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED : 3000 UNIT. It is listed in the Health Canada Drug Product Database under DIN 02532964, held by NOVO NORDISK CANADA INC, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 13-Feb-2024. 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 REBINYN used for?
Routine prophylaxis, control and prevention of bleeding episodes, and perioperative management in adults and children with hemophilia B (congenital factor IX deficiency).
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 Coagulation Factor Ix 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.
8 holders have a Canadian DIN containing Coagulation Factor Ix, across 33 DINs, of which 16 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 |
|---|---|---|---|---|
| PFIZER CANADA ULC | 6 | 4 | BENEFIX | Sourceable in Canada |
| SANOFI-AVENTIS CANADA INC | 6 | 4 | ALPROLIX | Sourceable in Canada |
| TAKEDA CANADA INC | 6 | 4 | IMMUNINE VH, RIXUBIS | Sourceable in Canada |
| NOVO NORDISK CANADA INC | 4 | 4 | REBINYN | Sourceable in Canada |
| CSL BEHRING CANADA INC | 5 | 0 | IDELVION | No marketed DIN |
| WYETH CANADA | 3 | 0 | BENEFIX - (250IU), BENEFIX - (500IU), BENEFIX -(1000IU) | No marketed DIN |
| OSTERREICHISCHES INSTITUT FUR HAEMODERIVATE GES M.B.H. | 2 | 0 | BEBULIN VH 500UNIT/VIAL, BEBULIN VH INJ 1000UNIT/VIAL | No marketed DIN |
| ALPHA THERAPEUTIC CORPORATION | 1 | 0 | ALPHANINE PWS INJ 1500UNIT/VIAL | 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 | 3000 UNIT |
|---|---|
| Dosage form | POWDER FOR SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | Package contains 1 glass vial of powder, 1 MixPro prefilled solvent syringe (4 mL histidine solvent), 1 vial adapter, and 1 plunger rod. |
| Storage | Reconstituted: use immediately or within 4 hours at room temp (up to 30°C) or 24 hours in refrigerator (2°C–8°C). Do not freeze. Keep out of direct light. |
| Shipping class | Cold chain — validated shipper with temperature monitoring |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Cold chain. This product is stored refrigerated. Nexara ships it on a validated cold chain with temperature monitoring; a delivery address that cannot receive and store it at 2–8 °C on arrival must be flagged before the order is placed.
Substance and classification
| Active substance | Coagulation Factor Ix |
|---|---|
| ATC code | B02BD04 |
| AHFS class | 20:28.16 |
| 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) | 02532964 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2532964 |
| Brand name | REBINYN |
| Generic / active ingredient | COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED : 3000 UNIT |
| Market authorization holder | NOVO NORDISK CANADA INC |
| Health Canada schedule | Schedule D |
| ATC code | B02BD04 |
| ATC anatomical main group | B — Blood and blood-forming organs |
| ATC therapeutic subgroup | B02BD |
| Current status | MARKETED |
| Status date | 13-Feb-2024 |
| Original market date | 2024-02-13 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Intravenous bolus injection. Routine prophylaxis: 40 IU/kg once weekly. Control of bleeding: 40-80 IU/kg. Perioperative: 40-80 IU/kg. Max rate 4 mL/min.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to the drug, any ingredient in the formulation (including hamster protein), or component of the container. Not indicated for immune tolerance induction.
Warnings and precautions
Risk of thromboembolic events, hypersensitivity/anaphylaxis, and inhibitor formation. PEG deposition in brain tissues seen in animals; monitor for neurological/cognitive changes.
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
16 of 33 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ALPROLIX | 500 UNIT | KIT ; POWDER FOR SOLUTION | SANOFI-AVENTIS CANADA INC | MARKETED | 02422913 |
| ALPROLIX | 1000 UNIT | KIT ; POWDER FOR SOLUTION | SANOFI-AVENTIS CANADA INC | MARKETED | 02422921 |
| ALPROLIX | 2000 UNIT | POWDER FOR SOLUTION ; KIT | SANOFI-AVENTIS CANADA INC | MARKETED | 02422948 |
| ALPROLIX | 3000 UNIT | KIT ; POWDER FOR SOLUTION | SANOFI-AVENTIS CANADA INC | MARKETED | 02422956 |
| BENEFIX | 3000 UNIT | POWDER FOR SOLUTION | PFIZER CANADA ULC | MARKETED | 02392984 |
| BENEFIX | 2000 UNIT | POWDER FOR SOLUTION | PFIZER CANADA ULC | MARKETED | 02293803 |
| BENEFIX | 1000 UNIT | POWDER FOR SOLUTION | PFIZER CANADA ULC | MARKETED | 02293781 |
| BENEFIX | 500 UNIT | POWDER FOR SOLUTION | PFIZER CANADA ULC | MARKETED | 02293773 |
| IMMUNINE VH | 720 UNIT / 5 ML | POWDER FOR SOLUTION | TAKEDA CANADA INC | MARKETED | 02206021 |
| REBINYN | 500 UNIT | POWDER FOR SOLUTION | NOVO NORDISK CANADA INC | MARKETED | 02470187 |
2 · Same class — other molecules in ATC B02BD
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Coagulation Factor Viii | ADVATE · ADYNOVATE · AFSTYLA · ALTUVIIIO · +34 more | 134 | 38 | Yes |
| Coagulation Factor Ix | ALPHANINE PWS INJ 1500UNIT/VIAL · ALPROLIX · BEBULIN VH 500UNIT/VIAL · BEBULIN VH INJ 1000UNIT/VIAL · +8 more | 33 | 16 | Yes |
| Von Willebrand Factor And Coag. Fact. Viii In Comb | ALPHANATE · HUMATE-P · WILATE | 10 | 5 | Yes |
| Coagulation Factor Ix, Ii, Vii And X In Comb | BERIPLEX P/N 1000 · BERIPLEX P/N 500 · OCTAPLEX | 4 | 4 | Yes |
| Coagulation Factor Viia | NIASTASE · NIASTASE RT | 11 | 3 | Yes |
| Factor Viii Inhibitor Bypassing Activity | FEIBA NF · FEIBA VH IMMUNO ANTI INHIBITOR | 5 | 2 | Yes |
| Coagulation Factor Xiii | CORIFACT 1250 · CORIFACT 250 | 2 | 2 | Yes |
| Thrombin | RECOTHROM · THROMBOGEN SPRAY KIT · VISTASEAL | 4 | 1 | Yes |
| Catridecacog | TRETTEN | 1 | 1 | Yes |
| Etranacogene Dezaparvovec | HEMGENIX | 1 | 1 | Yes |
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 B02B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| B02BX | Avatrombopag · Concizumab · Eltrombopag · Emicizumab · Fostamatinib · +1 more | 23 | 15 |
| B02BC | Combinations · Epinephrine · Local Hemostatics · Thrombin | 23 | 6 |
| B02BA | Phytomenadione | 5 | 2 |
| B02BB | Fibrinogen, Human | 2 | 2 |
4 · Fixed-dose combinations with Canadian supply
| Product | Active ingredients | Holder | Status | DIN |
|---|---|---|---|---|
| ADYNOVATE | ANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED : 1000 UNIT | TAKEDA CANADA INC | MARKETED | 02498588 |
| ALPROLIX | RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN : 500 UNIT | SANOFI-AVENTIS CANADA INC | MARKETED | 02422913 |
| ALTUVIIIO | *ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, BDD), FC-VWF-XTEN FUSION PROTEIN : 4000 UNIT | SANOFI-AVENTIS CANADA INC | MARKETED | 02448157 |
| ELOCTATE | ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN : 500 UNIT | SANOFI-AVENTIS CANADA INC | MARKETED | 02430304 |
| ESPEROCT | ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED : 2000 UNIT | NOVO NORDISK CANADA INC | MARKETED | 02490099 |
| JIVI | ANTIHEMOPHILIC FACTOR (RECOMBINANT, B-DOMAIN DELETED, PEGYLATED) : 1000 UNIT | BAYER INC | MARKETED | 02481774 |
| REBINYN | COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED : 3000 UNIT | NOVO NORDISK CANADA INC | MARKETED | 02532964 |
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?
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. 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.