Medicine
Enjaymo 1100 mg/22 mL injection
Enjaymo 1100 mg/22 mL injection is a prescription medicine containing Sutimlimab for intravenous use, marketed by Recordati Rare Diseases, 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 ENJAYMO vials refrigerated at 36°F to 46°F (2°C to 8°C) in the original…
Key facts
- Active ingredient (INN)
- Sutimlimab
- Brand
- Enjaymo
- Strength
- 1100 mg/22 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 22 mL
- Marketing authorisation holder
- Recordati Rare Diseases
- Manufacturer
- Recordati Rare Diseases
- Origin register
- US FDA, United States
- Storage
- Store ENJAYMO vials refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not freeze. Do not shake.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AJ04 Sutimlimab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 February 2022
- Identifiers
- RxCUI 2591419, 2591425DailyMed set ID 0a25363a-7781-d9f8-cb1c-be22987bf03bNDC 55292-820Application BLA761164
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-dose in 1 carton / 22 mL in 1 vial, single-dose | 55292-820-01 | Recordati Rare Diseases | 25 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.
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
Sutimlimab is a classical complement pathway inhibitor indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD). It is available as injection for intravenous use. MedsAcross supplies Sutimlimab 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 SutimlimabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Enjaymo prescribing information (Recordati Rare Diseases) · U.S. National Library of Medicine, DailyMed
- Enjaymo: European public assessment report (EPAR) · European Medicines Agency
Need Enjaymo 1100 mg/22 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.