Is Isatuximab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Isatuximab, including Sarclisa (20 mg/ml, Concentrate for solution for infusion, SAR 2327.05).

Is Isatuximab approved by the US FDA?

Drugs@FDA lists 2 application product lines for Isatuximab, including SARCLISA (Prescription); SARCLISA ESCENA (Prescription).

Is Isatuximab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Isatuximab: Sarclisa.

Are there safety signals or safety updates for Isatuximab?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2026-06-26).

Active substance

Isatuximab

SFDA 2
US FDA 2
EMA 1
Health Canada 2
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Sarclisa	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 2327.05	Biological · Prescription	SANOFI AVENTIS GROUPE	Valid
Sarclisa	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 10284.70	Biological · Prescription	SANOFI AVENTIS GROUPE	Valid

Indications — CHI Daman Drug Formulary

AMYLOIDOSIS - LIGHT CHAIN; MULTIPLE MYELOMA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
SARCLISA	100MG/5ML (20MG/ML); 500MG/25ML (20MG/ML)	injectable · injection	SANOFI AVENTIS US	Prescription	2 Mar 2020
SARCLISA ESCENA	1400MG/10ML (140MG/ML)	vial · single-dose	SANOFI-AVENTIS U.S. LLC	Prescription	9 Jul 2026

EMA European Union — centrally authorised medicines

Sarclisa Sanofi Winthrop Industrie · Authorised · authorised 30 May 2020 · ATC L01XC38

Therapeutic indication (EMA)

Sarclisa is indicated: In combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. In combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. In combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. In combination with bortezomib, lenalidomide, and dexamethasone, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SARCLISA	02498235	100 MG / 5 ML	SOLUTION · INTRAVENOUS	SANOFI-AVENTIS CANADA INC
SARCLISA	02498243	500 MG / 25 ML	SOLUTION · INTRAVENOUS	SANOFI-AVENTIS CANADA INC

Safety signals and safety-related labeling changes

US FDA 26 Jun 2026 SARCLISA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 1 Oct 2020 PRAC signal: Anaphylactic reaction
Action for MAH: update of the product information: No

All safety entries for isatuximab →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.