Medicine
Rebinyn kit
Rebinyn kit is a prescription medicine containing Coagulation factor ix recombinant, marketed by Novo Nordisk, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store REBINYN in the original package in order to protect from light. • Store…
Key facts
- Active ingredient (INN)
- Coagulation factor ix recombinant
- Brand
- Rebinyn
- Dosage form
- Kit
- Packs
- 1 kit and 1 more
- Marketing authorisation holder
- Novo Nordisk
- Manufacturer
- Novo Nordisk
- Origin register
- US FDA, United States
- Storage
- Store REBINYN in the original package in order to protect from light. • Store REBINYN under refrigeration at a temperature of 36°F-46°F (2°C – 8°C) for up to 24 months from the date of manufacture until the expiration date stated on the label. • REBINYN may be stored at room temperature not to exceed 86°F (30°C) for up to 6 months within the 24-month time period.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.12Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 December 2017
- Identifiers
- RxCUI 1990857, 1990862DailyMed set ID 0ea37235-35fd-410d-b8c4-40ba15fe1294NDC 0169-7905, 0169-7902, 0169-7901 +1Application BLA125611
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 kit in 1 kit * 4 mL in 1 vial, glass * 4 mL in 1 syringe, glass * 4 mL in 1 vial, glass | 0169-7901-01 | Novo Nordisk | 1 December 2017 |
| 1 kit in 1 kit * 4 mL in 1 vial, glass * 4 mL in 1 syringe, glass * 4 mL in 1 vial, glass | 0169-7902-01 | Novo Nordisk | 1 December 2017 |
| 1 kit in 1 kit * 4 mL in 1 vial, glass * 4 mL in 1 syringe, glass | 0169-7903-01 | Novo Nordisk | 11 August 2022 |
| 1 kit in 1 kit * 4 mL in 1 vial, glass * 4 mL in 1 syringe, glass * 4 mL in 1 vial, glass | 0169-7905-01 | Novo Nordisk | 1 December 2017 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Coagulation factor ix recombinant is a prescription medicine indicated in adults and children with hemophilia B (congenital Factor IX deficiency) for on-demand treatment and control of bleeding episodes, among other approved uses. MedsAcross supplies Coagulation factor ix recombinant for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Coagulation factor ix recombinantFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- REBINYN prescribing information (Novo Nordisk) · U.S. National Library of Medicine, DailyMed
Need Rebinyn kit for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.