Medicine
Cuvitru 8000 mg/40 mL injection
Cuvitru 8000 mg/40 mL injection is a prescription medicine containing Human immunoglobulin g for subcutaneous use, marketed by Takeda Pharmaceuticals, 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 at refrigeration temperature: 2°C to 8°C [36°F to 46°F] for up to 36…
Key facts
- Active ingredient (INN)
- Human immunoglobulin g
- Brand
- Cuvitru
- Strength
- 8000 mg/40 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 vial of 40 mL
- Marketing authorisation holder
- Takeda Pharmaceuticals
- Manufacturer
- Takeda Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at refrigeration temperature: 2°C to 8°C [36°F to 46°F] for up to 36 months or Room temperature: not to exceed 25°C [77°F]) for up to 24 months. Do not return CUVITRU to the refrigerator if you take it out to room temperature. Do not freeze. Do not shake. Keep the vials in the 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
- 18 October 2016
- Identifiers
- RxCUI 1809061, 1809066, 1809068 +7DailyMed set ID 9aad7ec9-6097-4805-8f1b-898bec35f218NDC 0944-2850Application BLA125596
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, single-use in 1 carton / 40 mL in 1 vial, single-use | 0944-2850-07 | Takeda Pharmaceuticals | 18 October 2016 |
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
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 Cuvitru 8000 mg/40 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.