REBINYN 500 UNIT
COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED : 500 UNIT · DIN 02470187 · NOVO NORDISK CANADA INC
Health Canada status: MARKETED
What is REBINYN?
REBINYN 500 UNIT contains COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED : 500 UNIT. It is listed in the Health Canada Drug Product Database under DIN 02470187, held by NOVO NORDISK CANADA INC, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 23-Mar-2018. 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?
Rebinyn® is an anti-hemophilic factor indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for: routine prophylaxis to prevent or reduce the frequency of bleeding episodes, control and prevention of bleeding episodes, control and prevention of bleeding in the perioperative setting.
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 | 02470187 |
|---|---|
| Brand name | REBINYN |
| Generic / active ingredient | COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED : 500 UNIT |
| Manufacturer | NOVO NORDISK CANADA INC |
| Strength | 500 UNIT |
| Dosage form | POWDER FOR SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Schedule D |
| ATC code | B02BD04 COAGULATION FACTOR IX |
| AHFS class | 20:28.16 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 23-Mar-2018 |
| Original market date | 2018-03-23 00:00:00 |
How is it stored and handled?
The reconstituted product should be used within 4 hours when stored at room temperature (up to 30°C) and within 24 hours when stored in a refrigerator (at 2°C – 8°C). Store the reconstituted product in the vial. Do not freeze reconstituted Rebinyn® solution or store it in syringes. Keep reconstituted Rebinyn® solution out of direct light.
How is it supplied?
1 glass vial (type I) with Rebinyn® powder and chlorobutyl rubber stopper, 1 sterile vial adapter (with 25 micrometer filter) for reconstitution, 1 prefilled syringe containing 4 mL of histidine solvent with a backstop (polypropylene), a rubber plunger (bromobutyl), and a tip cap with a stopper (bromobutyl), 1 plunger rod (polypropylene)
What can be used instead?
Other Canadian products sharing ATC code B02BD04 COAGULATION FACTOR IX. 16 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 |
|---|---|---|---|---|---|
| ALPROLIX | 1000 UNIT | KIT ; POWDER FOR SOLUTION | SANOFI-AVENTIS CANADA INC | MARKETED | DIN 02422921 |
| ALPROLIX | 2000 UNIT | POWDER FOR SOLUTION ; KIT | SANOFI-AVENTIS CANADA INC | MARKETED | DIN 02422948 |
| ALPROLIX | 3000 UNIT | KIT ; POWDER FOR SOLUTION | SANOFI-AVENTIS CANADA INC | MARKETED | DIN 02422956 |
| ALPROLIX | 500 UNIT | KIT ; POWDER FOR SOLUTION | SANOFI-AVENTIS CANADA INC | MARKETED | DIN 02422913 |
| BENEFIX | 1000 UNIT | POWDER FOR SOLUTION | PFIZER CANADA ULC | MARKETED | DIN 02293781 |
| BENEFIX | 2000 UNIT | POWDER FOR SOLUTION | PFIZER CANADA ULC | MARKETED | DIN 02293803 |
| BENEFIX | 3000 UNIT | POWDER FOR SOLUTION | PFIZER CANADA ULC | MARKETED | DIN 02392984 |
| BENEFIX | 500 UNIT | POWDER FOR SOLUTION | PFIZER CANADA ULC | MARKETED | DIN 02293773 |
| IMMUNINE VH | 720 UNIT / 5 ML | POWDER FOR SOLUTION | TAKEDA CANADA INC | MARKETED | DIN 02206021 |
| REBINYN | 1000 UNIT | POWDER FOR SOLUTION | NOVO NORDISK CANADA INC | MARKETED | DIN 02470268 |
Who else supplies COAGULATION FACTOR IX worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. COAGULATION FACTOR IX appears in 109 registered pack listings across 5 markets, published on 3 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.