Medicine
VYVGART Hytrulo 200 mg/2000 units per mL injection
VYVGART Hytrulo 200 mg/2000 units per mL injection is a prescription medicine containing Efgartigimod alfa and Hyaluronidase (human recombinant) for subcutaneous use, marketed by argenx, 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 VYVGART HYTRULO vials refrigerated at 2°C to 8°C (36°F to 46°F) in the…
Key facts
- Active ingredient (INN)
- Efgartigimod alfa and Hyaluronidase (human recombinant)
- Brand
- VYVGART Hytrulo
- Strength
- 200 mg/2000 units per mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 syringe, 4 syringes
- Marketing authorisation holder
- argenx
- Manufacturer
- argenx
- Origin register
- US FDA, United States
- Storage
- Store VYVGART HYTRULO vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Do not freeze. If needed, unopened vials may be stored in the original carton for up to 3 days at room temperature at 20°C to 25°C (68°F to 77°F) for a single period before administration or returned to refrigeration.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 April 2025
- Identifiers
- RxCUI 2639951, 2639957, 2712083 +1DailyMed set ID 7104d9e5-9910-47f5-9a93-741ac50f43b6NDC 73475-1221Application BLA761304
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
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 Efgartigimod alfa and Hyaluronidase (human recombinant)
Clinical summary
Efgartigimod alfa and Hyaluronidase (human recombinant) is a fixed-dose combination of an endoglycosidase and a neonatal Fc receptor blocker. It is available as injection for subcutaneous use. MedsAcross supplies Efgartigimod alfa and Hyaluronidase (human recombinant) 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 Efgartigimod alfa and Hyaluronidase (human recombinant)For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- VYVGART Hytrulo prescribing information (argenx) · U.S. National Library of Medicine, DailyMed
Need VYVGART Hytrulo 200 mg/2000 units per 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.