Medicine
Fayuvi kit
Fayuvi kit is a prescription medicine containing Rebisufligene etisparvovec, marketed by Ultragenyx Pharmaceutical, 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 upright at ≤ -60°C [-76°F]. Once drawn from the vial and prepared in…
Key facts
- Active ingredient (INN)
- Rebisufligene etisparvovec
- Brand
- Fayuvi
- Dosage form
- Kit
- Packs
- 1 kit and 28 more
- Marketing authorisation holder
- Ultragenyx Pharmaceutical
- Manufacturer
- Ultragenyx Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- Store upright at ≤ -60°C [-76°F]. Once drawn from the vial and prepared in syringes, FAYUVI can be stored at room temperature (20°C – 25°C [68°F – 77°F]) for up to 24 hours, including time for infusion.
- 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
- 31 October 2026
- Identifiers
- DailyMed set ID 996fc33a-26d3-4fae-bd0c-a2edd7764539NDC 69794-322, 69794-323, 69794-327 +28Application BLA125845
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 * 2 mL in 1 vial | 69794-301-05 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-302-06 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-303-08 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-305-11 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-306-12 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-307-14 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-308-15 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-309-18 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-310-21 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-311-24 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-312-27 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-313-30 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-314-33 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-315-36 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-316-39 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-317-42 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-318-45 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-319-48 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-320-51 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-321-54 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-322-57 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-323-60 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-324-63 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-325-69 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-326-75 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-327-81 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-328-87 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-329-93 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-330-99 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-331-05 | Ultragenyx Pharmaceutical | 31 October 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-346-09 | Ultragenyx Pharmaceutical | 31 October 2026 |
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
Rebisufligene etisparvovec is a prescription medicine indicated for the treatment of neurologic manifestations of mucopolysaccharidosis type IIIA (MPS IIIA, Sanfilippo syndrome type A) in pediatric patients with preserved neurodevelopmental function. It is available as kits. MedsAcross supplies Rebisufligene etisparvovec 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 Rebisufligene etisparvovecFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- FAYUVI prescribing information (Ultragenyx Pharmaceutical) · U.S. National Library of Medicine, DailyMed
Need Fayuvi 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.