Medicine
QIVIGY kthm 5 g/50 mL injection
QIVIGY kthm 5 g/50 mL injection is a prescription medicine containing Human immunoglobulin g for intravenous use, marketed by Kedrion, 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 QIVIGY at 2 °C - 8 °C (36 °F - 46 °F) for up to 36 months. Do not…
Key facts
- Active ingredient (INN)
- Human immunoglobulin g
- Brand
- QIVIGY kthm
- Strength
- 5 g/50 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 50 mL
- Marketing authorisation holder
- Kedrion
- Manufacturer
- Kedrion
- Origin register
- US FDA, United States
- Storage
- Store QIVIGY at 2 °C - 8 °C (36 °F - 46 °F) for up to 36 months. Do not freeze. Keep the vial stored in the outer carton in order to protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J06BA02 Human immunoglobulin g
- HS code (indicative)
- 3002.12Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 September 2025
- Identifiers
- RxCUI 2726016, 2726023, 2726025 +1DailyMed set ID 6f1933e0-240f-48f4-b246-8a30e63a4160NDC 76179-010Application BLA125822
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 vial, glass in 1 carton / 50 mL in 1 vial, glass | 76179-010-02 | Kedrion | 26 September 2025 |
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
Alternatives
Other makers and brands of Human immunoglobulin g 5 g/50 mL injection.
- Yimmugo 5 g/50 mL injectionAvailable on requestBiotestUS FDA2 packs Cold chain
- Asceniv 5 g/50 mL injectionAvailable on requestADMA BiologicsUS FDA1 pack Cold chain
- Bivigam 5 g/50 mL injectionAvailable on requestADMA BiologicsUS FDA1 pack Cold chain
- Gammaked 5 g/50 mL injectionAvailable on requestKedrion BiopharmaUS FDA1 pack
- Gammaplex 5 g/50 mL injectionAvailable on requestBio Products LaboratoryUS FDA1 pack
- Gamunex-C 5 g/50 mL injectionAvailable on requestGrifolsUS FDA1 pack
Other strengths and forms of Human immunoglobulin g
Clinical summary
Human immunoglobulin g is a human immunoglobulin G indicated for the treatment of adults and pediatric patients 2 years of age and older with primary humoral immunodeficiency (PI). MedsAcross supplies Human immunoglobulin g 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 Human immunoglobulin gFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- BIVIGAM prescribing information (ADMA Biologics) · U.S. National Library of Medicine, DailyMed
Need QIVIGY kthm 5 g/50 mL injection 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.