Medicine
Zanvastro kit
Zanvastro kit is a prescription medicine containing Zilganersen, marketed by Ionis Pharmaceuticals, 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 the ZANVASTRO vial and diluent vial in the refrigerator between 2°C and…
Key facts
- Active ingredient (INN)
- Zilganersen
- Brand
- Zanvastro
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- Ionis Pharmaceuticals
- Manufacturer
- Ionis Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store the ZANVASTRO vial and diluent vial in the refrigerator between 2°C and 8°C (36°F and 46°F) in the original carton to protect from light. Once taken out of the refrigerator, the ZANVASTRO vial and diluent vial can be stored at room temperature up to 30°C (86°F) in the original carton for up to 14 days. If not used within the 14 days stored at room temperature, discard ZANVASTRO.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 September 2026
- Identifiers
- RxCUI 2753034, 2753040DailyMed set ID af6ca330-46d3-4ed6-b2af-bd6db3133fd1NDC 71860-304Application NDA220210
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 * 21 mL in 1 vial, single-dose * 2.8 mL in 1 vial, single-dose | 71860-304-01 | Ionis Pharmaceuticals | 3 September 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 |
| US FDA | First approved 3 September 2026 | Drugs@FDA |
| 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
Zilganersen is a prescription medicine indicated for the treatment of Alexander disease in pediatric and adult patients. It is available as kits. MedsAcross supplies Zilganersen 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 ZilganersenFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ZANVASTRO prescribing information (Ionis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Zanvastro 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.