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Skysona 30000000 injectable suspension

Elivaldogene autotemcel · Intravenous · Genetix Biotherapeutics
Available on requestPrescription onlyUS FDA Cold chain

Skysona 30000000 injectable suspension is a prescription medicine containing Elivaldogene autotemcel for intravenous use, marketed by Genetix Biotherapeutics, 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Cold chain

Do not re-freeze after thawing. Store SKYSONA frozen in the vapor phase of…

Key facts

Active ingredient (INN)
Elivaldogene autotemcel
Brand
Skysona
Strength
30000000
Dosage form
Injectable suspension
Route
Intravenous
Packs
1 suspension
Marketing authorisation holder
Genetix Biotherapeutics
Manufacturer
Genetix Biotherapeutics
Origin register
US FDA, United States
Storage
Do not re-freeze after thawing. Store SKYSONA frozen in the vapor phase of liquid nitrogen at less than or equal to -140°C (-220°F) until ready for thaw and administration.
Cold chain
Yes, shipped temperature controlled
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
N07 Other nervous system medicines
HS code (indicative)
3002.51Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
16 September 2022
Identifiers
RxCUI 2612552, 2612558DailyMed set ID f189502b-dc44-4289-99a6-cfba36918329NDC 73554-2111Application BLA125755

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

PackCodeLabelerMarketed since
1 suspension in 1 bag73554-2111-1Genetix Biotherapeutics16 September 2022

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
EU (EMA)WithdrawnEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS 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

Elivaldogene autotemcel is a prescription medicine indicated to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD), among other approved uses. MedsAcross supplies Elivaldogene autotemcel 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 Elivaldogene autotemcel

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Skysona 30000000 injectable suspension 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.