Medicine
Sarclisa 500 mg/25 mL injection
Sarclisa 500 mg/25 mL injection is a prescription medicine containing Isatuximab for intravenous use, marketed by Sanofi-Aventis, 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 in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to…
Key facts
- Active ingredient (INN)
- Isatuximab
- Brand
- Sarclisa
- Strength
- 500 mg/25 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 25 mL
- Marketing authorisation holder
- Sanofi-Aventis
- Manufacturer
- Sanofi-Aventis
- Origin register
- US FDA, United States
- Storage
- Store in a refrigerator 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
- L01XC38 Isatuximab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 2 March 2020
- Identifiers
- RxCUI 2282023, 2282028, 2282031 +1DailyMed set ID a0473462-6f9d-4eca-a5bf-8620aea68e8aNDC 0024-0656Application BLA761113
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 / 25 mL in 1 vial, single-dose | 0024-0656-01 | Sanofi-Aventis | 2 March 2020 |
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
Other strengths and forms of Isatuximab
Clinical summary
Isatuximab is a CD38-directed cytolytic antibody indicated in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. MedsAcross supplies Isatuximab 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 IsatuximabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Sarclisa prescribing information (Sanofi-Aventis) · U.S. National Library of Medicine, DailyMed
- Sarclisa: European public assessment report (EPAR) · European Medicines Agency
Need Sarclisa 500 mg/25 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.