Medicine
Waskyra 1000000 units/mL injection
Waskyra 1000000 units/mL injection is a prescription medicine containing Etuvetidigene autotemcel for intravenous use, marketed by Fondazione Telethon ETS, 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not re-freeze after thawing. Store WASKYRA ® in the vapor phase of liquid…
Key facts
- Active ingredient (INN)
- Etuvetidigene autotemcel
- Brand
- Waskyra
- Strength
- 1000000 units/mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 20 mL
- Marketing authorisation holder
- Fondazione Telethon ETS
- Manufacturers
- Fondazione Telethon ETSOrphan Therapies
- Origin register
- US FDA, United States
- Storage
- Do not re-freeze after thawing. Store WASKYRA ® in the vapor phase of liquid nitrogen at less than -130°C (-202°F) until ready for thaw and administration.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B06 Other blood-related medicines
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 July 2026
- Identifiers
- RxCUI 2747661, 2747667DailyMed set ID 106880df-7a30-4a0f-9e16-9f20fcc7d138, 45929c87-685d-b21c-e063-6394a90a3818NDC 87668-0100, 87233-0100Application BLA125846
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 |
|---|---|---|---|
| 20 mL in 1 bag | 87233-0100-1 | Fondazione Telethon ETS | 23 July 2026 |
| 20 mL in 1 bag | 87668-0100-1 | Orphan Therapies | 23 July 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.
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
Etuvetidigene autotemcel is a prescription medicine indicated for the treatment of pediatric patients aged 6 months and older and adults with Wiskott-Aldrich Syndrome (WAS), among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Etuvetidigene 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 Etuvetidigene autotemcelFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- WASKYRA prescribing information (Fondazione Telethon ETS) · U.S. National Library of Medicine, DailyMed
- Waskyra: European public assessment report (EPAR) · European Medicines Agency
Need Waskyra 1000000 units/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.