Medicine
Zevaskyn 40 cm2 cellular sheet
Zevaskyn 40 cm2 cellular sheet is a prescription medicine containing Prademagene zamikeracel for topical use, marketed by Abeona Therapeutics, 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
Store and transport ZEVASKYN at room temperature (15-25°C). ZEVASKYN is stable…
Key facts
- Active ingredient (INN)
- Prademagene zamikeracel
- Brand
- Zevaskyn
- Strength
- 40 cm2
- Dosage form
- Cellular sheet
- Route
- Topical
- Packs
- 4 cellular sheet
- Marketing authorisation holder
- Abeona Therapeutics
- Manufacturer
- Abeona Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store and transport ZEVASKYN at room temperature (15-25°C). ZEVASKYN is stable for 84 hours at room temperature and must be used within 84 hours.
- Cold chain
- Not required on record
- 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
- 15 June 2025
- Identifiers
- RxCUI 2713347, 2713352DailyMed set ID f8782480-8782-4748-9764-b9ed60979d47NDC 84103-007Application BLA125807
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 |
|---|---|---|---|
| 4 cellular sheet in 1 bag | 84103-007-01 | Abeona Therapeutics | 15 June 2025 |
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
Prademagene zamikeracel is a prescription medicine indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). It is available as cellular sheet for topical use. MedsAcross supplies Prademagene zamikeracel 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 Prademagene zamikeracelFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ZEVASKYN prescribing information (Abeona Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Zevaskyn 40 cm2 cellular sheet 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.