Molecule
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
From the regulator-approved product information. Each section names its source.
ZEVASKYN is indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). ZEVASKYN is an autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).
Source: US FDA prescribing information
In patients with recessive dystrophic epidermolysis bullosa (RDEB), both copies of the COL7A1 gene are mutated, resulting in the absence or low levels of biologically active C7 protein which form anchoring fibrils (AFs). The lack of AFs disrupts the connection between the epidermis and the dermis and causes skin fragility and other signs and symptoms of RDEB. ZEVASKYN consists of a patient's own cells that have been gene-modified through RVV transduction to express the COL7A1 gene to produce the C7 protein. These cells are formed into cellular sheets for topical application onto wounds.
Source: US FDA prescribing information
For autologous topical application on wounds only The recommended dose of ZEVASKYN is based on the surface area of the wound(s). One sheet of ZEVASKYN covers an area of 41.25 cm 2. Up to twelve ZEVASKYN sheets may be manufactured from the patient biopsies and supplied for potential use. Verify the patient’s identity prior to ZEVASKYN application. See full prescribing information for ZEVASKYN preparation, and administration instructions. Figure 1
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Hypersensitivity reactions to vancomycin, amikacin, or product excipients may occur with ZEVASKYN application. Retroviral vector (RVV)-mediated insertional oncogenesis may potentially occur after treatment with ZEVASKYN. Transmission of Infectious Agents may occur because ZEVASKYN is manufactured using human- and bovine-derived reagents.
Source: US FDA prescribing information
The most common adverse reactions (incidence ≥5%) were procedural pain and pruritus.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Prademagene zamikeracel, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Zevaskyn 40 cm2 cellular sheetTopical | Abeona Therapeutics | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | Not recorded | — |
| 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 |
Yes, on request. MedsAcross lists 1 presentations of Prademagene zamikeracel and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Prademagene zamikeracel, including Zevaskyn.
No listed presentation of Prademagene zamikeracel is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.