Medicine
Idelvion kit
Idelvion kit is a prescription medicine containing Coagulation factor ix recombinant human, marketed by CSL Behring Lengnau, 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 the IDELVION package in the refrigerator or at room temperature 2-25°C…
Key facts
- Active ingredient (INN)
- Coagulation factor ix recombinant human
- Brand
- Idelvion
- Dosage form
- Kit
- Packs
- 1 kit and 2 more
- Marketing authorisation holder
- CSL Behring Lengnau
- Manufacturer
- CSL Behring Lengnau
- Origin register
- US FDA, United States
- Storage
- Store the IDELVION package in the refrigerator or at room temperature 2-25°C (36 to 77°F). Do not freeze. Store IDELVION in its package to protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B02BD09 Nonacog alfa
- HS code (indicative)
- 3002.12Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 March 2016
- Identifiers
- RxCUI 1743994, 1743999DailyMed set ID f74301bf-95e2-44ab-a8b6-98aa07b04683NDC 69911-866, 69911-867, 69911-869 +2Application BLA125582
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 carton * 2.5 mL in 1 vial, single-use * 2.5 mL in 1 vial, single-use | 69911-864-02 | CSL Behring Lengnau | 4 March 2016 |
| 1 kit in 1 carton * 2.5 mL in 1 vial, single-use * 2.5 mL in 1 vial, single-use | 69911-865-02 | CSL Behring Lengnau | 4 March 2016 |
| 1 kit in 1 carton * 2.5 mL in 1 vial, single-use * 2.5 mL in 1 vial, single-use | 69911-866-02 | CSL Behring Lengnau | 4 March 2016 |
| 1 kit in 1 carton * 5 mL in 1 vial, single-use * 5 mL in 1 vial, single-use | 69911-867-02 | CSL Behring Lengnau | 4 March 2016 |
| 1 kit in 1 carton * 5 mL in 1 vial, single-use * 5 mL in 1 vial, single-use | 69911-869-02 | CSL Behring Lengnau | 30 May 2018 |
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 human is a prescription medicine. It is available as kits. MedsAcross supplies Coagulation factor ix recombinant human 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 recombinant humanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- IDELVION prescribing information (CSL Behring Lengnau) · U.S. National Library of Medicine, DailyMed
Need Idelvion 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.