Is Elotuzumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Elotuzumab.

Is Elotuzumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Elotuzumab, including EMPLICITI (Prescription).

Is Elotuzumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Elotuzumab: Empliciti.

Are there safety signals or safety updates for Elotuzumab?

US FDA: 1 entry (latest 2022-03-22).

Active substance

Elotuzumab

SFDA 2
US FDA 1
EMA 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
EMPLICITI 300 mg LYPHOILISATE FOR SOLUTION FOR INFUSION	300 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 4518.25	Biological · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed
EMPLICITI 400 mg LYPHOILISATE FOR SOLUTION FOR INFUSION	400 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 6024.35	Biological · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
EMPLICITI	300MG; 400MG	injectable · injection	BRISTOL MYERS SQUIBB	Prescription	30 Nov 2015

EMA European Union — centrally authorised medicines

Empliciti Bristol-Myers Squibb Pharma EEIG · Authorised · authorised 11 May 2016 · ATC L01FX08

Therapeutic indication (EMA)

Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1).

Safety signals and safety-related labeling changes

US FDA 22 Mar 2022 EMPLICITI — 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

All safety entries for elotuzumab →

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.