Medicine
Gamifant 250 mg/10 mL injection
Gamifant 250 mg/10 mL injection is a prescription medicine containing Emapalumab for intravenous use, marketed by Swedish Orphan Biovitrum AB (publ), 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 GAMIFANT in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF) in original…
Key facts
- Active ingredient (INN)
- Emapalumab
- Brand
- Gamifant
- Strength
- 250 mg/10 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 10 mL
- Marketing authorisation holder
- Swedish Orphan Biovitrum AB (publ)
- Manufacturer
- Swedish Orphan Biovitrum AB (publ)
- Origin register
- US FDA, United States
- Storage
- Store GAMIFANT in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF) in original carton to protect from light. Do not freeze or shake.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AG09 Emapalumab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 June 2023
- Identifiers
- RxCUI 2104611, 2104616, 2104621 +7DailyMed set ID a865e0ef-8685-4f69-8838-648c4f3bab47NDC 66658-524Application BLA761107
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 vial, single-use in 1 carton / 10 mL in 1 vial, single-use | 66658-524-01 | Swedish Orphan Biovitrum AB (publ) | 7 June 2023 |
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 20 November 2018 | Drugs@FDA |
| EU (EMA) | Refused | EMA medicines data |
| 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
Other strengths and forms of Emapalumab
Clinical summary
Emapalumab is an interferon gamma blocker indicated for the treatment of adult and pediatric patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. MedsAcross supplies Emapalumab 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 EmapalumabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- GAMIFANT prescribing information (Swedish Orphan Biovitrum AB (publ)) · U.S. National Library of Medicine, DailyMed
Need Gamifant 250 mg/10 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.