Is Elranatamab 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 Elranatamab, including Elrexfio (44 mg, Solution for injection, SAR 9907.90); Elrexfio (76 mg, Solution for injection, SAR 17113.70).

Is Elranatamab approved by the US FDA?

Drugs@FDA lists 1 application product line for Elranatamab, including ELREXFIO (Prescription).

Is Elranatamab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Elranatamab: Elrexfio.

Are there safety signals or safety updates for Elranatamab?

US FDA: 1 entry (latest 2026-02-19).

Active substance

Elranatamab

SFDA 2
US FDA 1
EMA 1
Health Canada 2
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
Elrexfio	44 mg	Solution for injection · Subcutaneous use	1 Vial	SAR 9907.90	Biological · Prescription	PFIZER INC	Valid
Elrexfio	76 mg	Solution for injection · Subcutaneous use	1 Vial	SAR 17113.70	Biological · Prescription	PFIZER INC	Valid

Indications — CHI Daman Drug Formulary

MULTIPLE MYELOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
ELREXFIO	12MG	solution · injection	PFIZER INC	Prescription	14 Aug 2023

EMA European Union — centrally authorised medicines

Elrexfio Pfizer Europe MA EEIG · Authorised · authorised 7 Dec 2023

Therapeutic indication (EMA)

Elrexfio is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ELREXFIO	02543559	44 MG / 1.1 ML	SOLUTION · SUBCUTANEOUS	PFIZER CANADA ULC
ELREXFIO	02543567	76 MG / 1.9 ML	SOLUTION · SUBCUTANEOUS	PFIZER CANADA ULC

Safety signals and safety-related labeling changes

US FDA 19 Feb 2026 ELREXFIO — safety-related labeling change
Labeling sections changed: Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for elranatamab →

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.