Isatuximab

Sarclisa Escena

1,400MG/10ML InjectionUnited StatesMarketedAuthorised 9 Jul 2026

In other countries

The same active substances on other registers, the same brand first.

SarclisaBrazil · Sanofi Medley Farmacêutica Ltda.Same brand
Sarclisa SCCanada · 1400 MG / 10 ML · Solution · Sanofi-Aventis Canada INCSame brand
SarclisaCanada · 100 MG / 5 ML · Solution · Sanofi-Aventis Canada INCSame brand
SarclisaCanada · 500 MG / 25 ML · Solution · Sanofi-Aventis Canada INCSame brand
Sarclisa 1 400 MG Solucion InyectableSpain · 140 mg/ml · solución inyectable · Sanofi Winthrop IndustrieSame brand
Sarclisa 20 MG/ML Concentrado Para Solucion Para PerfusionSpain · 20 mg · concentrado para solución para perfusión · Sanofi Winthrop IndustrieSame brand

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

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Isatuximab

Sarclisa Escena

1,400MG/10ML InjectionUnited StatesMarketedAuthorised 9 Jul 2026

Open in the registerAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Sarclisa 20 MG/ML Concentrado Para Solucion Para Perfusion

Spain · 20 mg · concentrado para solución para perfusión · Sanofi Winthrop Industrie

SarclisaEuropean Union · Sanofi Winthrop Industrie

SarclisaCroatia

SarclisaItaly · Concentrato per soluzione per infusione · Sanofi Winthrop Industrie

Sarclisa 1400 mg oplossing voor injectieNetherlands · Oplossing voor injectie · Sanofi Winthrop Industrie

Sarclisa 20 mg/ml, concentraat voor oplossing voor infusieNetherlands · Concentraat voor oplossing voor infusie · Sanofi Winthrop Industrie

SarclisaSaudi Arabia · Sanofi aventis Deutschland GmbH

Sarclisa Concentrate for Solution for Infusion 20MG/MLSingapore · 20mg/mL · infusion, solution concentrate · Sanofi-Aventis Singapore Pte. LTD.

Documents

The official texts, at the regulator.

Register entryFDA

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

U.S. Food and Drug Administration

FDA Purple Book, September 2026 release; acquired 2026-10-10T15:29:54.330165+00:00; exact source fields retained with source-key projections.

Licence: FDA-created structured factual administrative metadata; public-domain policy with third-party exceptions · Added 11 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Isatuximab
Strength: 1,400MG/10ML
Dosage form: Injection
Route: Subcutaneous
Register: United States (FDA)
Status: Marketed
Status in the register: Licensed / Rx
Authorised: 9 Jul 2026
Registration: BLA 761445
Marketing authorisation holder: Sanofi-Aventis U.S. LLC
Procedure: 351(a)
Supply: Rx