Is Talquetamab 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 Talquetamab, including Talvey (2 mg/ml, Solution for injection, SAR 1831.30); Talvey (40 mg/ml, Solution for injection, SAR 24417.20).

Is Talquetamab approved by the US FDA?

Drugs@FDA lists 1 application product line for Talquetamab, including TALVEY (Prescription).

Is Talquetamab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Talquetamab: Talvey.

Are there safety signals or safety updates for Talquetamab?

US FDA: 1 entry (latest 2025-10-02).

Active substance

Talquetamab

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
Talvey	2 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 1831.30	Biological · Prescription	JANSSEN PHARMACEUTICA N.V	Valid
Talvey	40 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 24417.20	Biological · Prescription	JANSSEN PHARMACEUTICA N.V	Valid

Indications — CHI Daman Drug Formulary

MULTIPLE MYELOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
TALVEY	3MG/1.5ML(2MG/ML); 40MG/ML	injectable · injection	JANSSEN BIOTECH	Prescription	9 Aug 2023

EMA European Union — centrally authorised medicines

Talvey · Authorised · authorised 21 Aug 2023 · ATC L01FX29

Therapeutic indication (EMA)

Talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 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
TALVEY	02547392	2 MG / ML	SOLUTION · SUBCUTANEOUS	JANSSEN INC
TALVEY	02547406	40 MG / ML	SOLUTION · SUBCUTANEOUS	JANSSEN INC

Safety signals and safety-related labeling changes

US FDA 2 Oct 2025 TALVEY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for talquetamab →

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.