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Medicine

Jivi kit

Available on requestPrescription onlyUS FDA Cold chain

Jivi kit is a prescription medicine containing Antihemophilic factor pegylated, marketed by Bayer HealthCare, 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Cold chain

Do not freeze. Once stored at room temperature, do not return the product to…

Key facts

Active ingredient (INN)
Antihemophilic factor pegylated
Brand
Jivi
Dosage form
Kit
Packs
1 kit and 7 more
Marketing authorisation holder
Bayer HealthCare
Manufacturer
Bayer HealthCare
Origin register
US FDA, United States
Storage
Do not freeze. Once stored at room temperature, do not return the product to the refrigerator. Store JIVI at +2°C to +8°C (36°F to 46°F) for up to 24 months from the date of manufacture. Within this period, JIVI may be stored for a single period of up to 6 months at temperatures up to +25°C or 77°F. Record the starting date of room temperature storage on the unopened product carton.
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
30 August 2018
Identifiers
RxCUI 2055659, 2055664DailyMed set ID f04e5bd5-d7e2-453b-a407-2616d81a695dNDC 0026-3946, 0026-3944, 0026-3948 +2Application BLA125661

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

PackCodeLabelerMarketed since
1 kit in 1 box * 2.5 mL in 1 vial * 2.5 mL in 1 syringe * 2.5 mL in 1 vial, single-use0026-3942-25Bayer HealthCare30 August 2018
1 kit in 1 box * 2.5 mL in 1 vial * 2.5 mL in 1 syringe * 2.5 mL in 1 vial, single-use0026-3942-99Bayer HealthCare30 August 2018
1 kit in 1 box * 2.5 mL in 1 vial * 2.5 mL in 1 syringe * 2.5 mL in 1 vial, single-use0026-3944-25Bayer HealthCare30 August 2018
1 kit in 1 box * 2.5 mL in 1 vial * 2.5 mL in 1 syringe * 2.5 mL in 1 vial, single-use0026-3944-99Bayer HealthCare30 August 2018
1 kit in 1 box * 2.5 mL in 1 vial * 2.5 mL in 1 syringe * 2.5 mL in 1 vial, single-use0026-3946-25Bayer HealthCare30 August 2018
1 kit in 1 box * 2.5 mL in 1 vial * 2.5 mL in 1 syringe * 2.5 mL in 1 vial, single-use0026-3946-99Bayer HealthCare30 August 2018
1 kit in 1 box * 2.5 mL in 1 vial * 2.5 mL in 1 syringe * 2.5 mL in 1 vial, single-use0026-3948-25Bayer HealthCare30 August 2018
1 kit in 1 box * 2.5 mL in 1 vial * 2.5 mL in 1 syringe * 2.5 mL in 1 vial, single-use0026-3948-99Bayer HealthCare30 August 2018
1 kit in 1 box * 5 mL in 1 vial * 5 mL in 1 syringe * 5 mL in 1 vial, single-use * 5 mL in 1 syringe0026-3950-50Bayer HealthCare2 December 2024
1 kit in 1 box * 5 mL in 1 vial * 5 mL in 1 syringe * 5 mL in 1 vial, single-use * 5 mL in 1 syringe0026-3950-99Bayer HealthCare2 December 2024

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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

Alternatives

Other makers and brands of Antihemophilic factor pegylated kit.

Compare 1

Clinical summary

Antihemophilic factor pegylated is a prescription medicine indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for on-demand treatment and control of bleeding episodes, among other approved uses. MedsAcross supplies Antihemophilic factor pegylated 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 Antihemophilic factor pegylated

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Jivi 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.