Medicine
Agamree kit
Agamree kit is a prescription medicine containing Vamorolone for oral use, marketed by Catalyst 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not freeze. Store the bottle upright at room temperature between 20°C to…
Key facts
- Active ingredient (INN)
- Vamorolone
- Brand
- Agamree
- Dosage form
- Kit
- Route
- Oral
- Packs
- 1 kit
- Marketing authorisation holder
- Catalyst Pharmaceuticals
- Manufacturer
- Catalyst Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store the bottle upright at room temperature between 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F) in the original carton. See USP controlled room temperature. After opening, store the bottle upright in a refrigerator 2°C to 8°C (36°F to 46°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- H02AB18 Vamorolone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 February 2024
- Identifiers
- RxCUI 2669804, 2669810DailyMed set ID fb376f09-cf9c-42b5-b4dd-02d5bcd73211NDC 69616-264Application NDA215239
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 * 100 mL in 1 bottle, glass | 69616-264-38 | Catalyst Pharmaceuticals | 1 February 2024 |
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
Vamorolone is a prescription medicine indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. It is available as kits for oral use. MedsAcross supplies Vamorolone 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 VamoroloneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- AGAMREE prescribing information (Catalyst Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Agamree: European public assessment report (EPAR) · European Medicines Agency
Need Agamree 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.