Medicine
Sevenfact kit
Sevenfact kit is a prescription medicine containing Coagulation factor viia recombinant human for intravenous use, marketed by Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB, 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not freeze. Do not freeze or store in syringes. Prior to reconstitution…
Key facts
- Active ingredient (INN)
- Coagulation factor viia recombinant human
- Brand
- Sevenfact
- Dosage form
- Kit
- Route
- Intravenous
- Packs
- 1 kit
- Marketing authorisation holder
- Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB
- Manufacturer
- Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Do not freeze or store in syringes. Prior to reconstitution, the SEVENFACT kit should be stored at room temperature but can be stored between 36°F to 86°F (2°C to 30°C), protected from light in the product package. After reconstitution, SEVENFACT should be stored at room temperature but can be stored between 36°F to 86°F (2°C to 30°C), for up to 4 hours.
- Cold chain
- Not required on record
- 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
- 10 December 2020
- Identifiers
- RxCUI 2386865, 2386870, 2386872 +3DailyMed set ID b23ad666-8ce0-4e0b-9eff-c6983ac5f7e6NDC 71127-1000, 71127-2000, 71127-5000Application BLA125641
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 package * 1 mL in 1 vial, single-dose * 1.1 mL in 1 syringe | 71127-1000-1 | Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB | 10 December 2020 |
| 1 kit in 1 package * 2 mL in 1 vial, single-dose * 2.2 mL in 1 syringe | 71127-2000-1 | Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB | 24 March 2025 |
| 1 kit in 1 package * 5 mL in 1 vial, single-dose * 5.2 mL in 1 syringe | 71127-5000-1 | Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB | 10 December 2020 |
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 viia recombinant human is a prescription medicine indicated for the treatment and control of bleeding episodes occurring in adults, among other approved uses. MedsAcross supplies Coagulation factor viia 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 viia 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
- Sevenfact prescribing information (Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB) · U.S. National Library of Medicine, DailyMed
Need Sevenfact 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.