Medicine
Hyqvia kit
Hyqvia kit is a prescription medicine containing Immune globulin infusion, 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
Do not freeze. Refrigeration: 2° to 8°C [36° to 46°F] for up to 36 months…
Key facts
- Active ingredient (INN)
- Immune globulin infusion
- Brand
- Hyqvia
- Dosage form
- Kit
- Packs
- 1 kit and 2 more
- Marketing authorisation holder
- Takeda Pharmaceuticals
- Manufacturer
- Takeda Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Refrigeration: 2° to 8°C [36° to 46°F] for up to 36 months. Room Temperature: up to 25°C [77°F] for up to 3 months during the first 24 months from the date of manufacturing (Mfg date) printed on the carton. HYQVIA must be used within 3 months after removal to room temperature but within the expiration date on the carton and vial label.
- 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
- 12 September 2014
- Identifiers
- RxCUI 1549687, 1549688, 1549689 +7DailyMed set ID 7ca2c26f-4be2-48cd-be5b-486e350654baNDC 0944-2513, 0944-2511, 0944-2510 +2Application BLA125402
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 * 25 mL in 1 vial, glass * 1.25 mL in 1 vial, glass | 0944-2510-02 | Takeda Pharmaceuticals | 12 September 2014 |
| 1 kit in 1 carton * 50 mL in 1 vial, glass * 2.5 mL in 1 vial, glass | 0944-2511-02 | Takeda Pharmaceuticals | 12 September 2014 |
| 1 kit in 1 carton * 100 mL in 1 vial, glass * 5 mL in 1 vial, glass | 0944-2512-02 | Takeda Pharmaceuticals | 12 September 2014 |
| 1 kit in 1 carton * 200 mL in 1 vial, glass * 10 mL in 1 vial, glass | 0944-2513-02 | Takeda Pharmaceuticals | 12 September 2014 |
| 1 kit in 1 carton * 300 mL in 1 vial, glass * 15 mL in 1 vial, glass | 0944-2514-02 | Takeda Pharmaceuticals | 12 September 2014 |
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
Immune globulin infusion is a prescription medicine indicated for the treatment of Primary Immunodeficiency (PI) in adults and pediatric patients two years of age and older, among other approved uses. It is available as kits. MedsAcross supplies Immune globulin infusion 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 Immune globulin infusionFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- HYQVIA prescribing information (Takeda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Hyqvia 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.