Is Teclistamab 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 Teclistamab, including Tecvayli (90 mg/ml, Solution for injection, SAR 22818.30); Tecvayli (10 mg/ml, Solution for injection, SAR 4474.25).

Is Teclistamab approved by the US FDA?

Drugs@FDA lists 1 application product line for Teclistamab, including TECVAYLI (Prescription).

Is Teclistamab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Teclistamab: Tecvayli.

Are there safety signals or safety updates for Teclistamab?

US FDA: 1 entry (latest 2026-03-05).

Active substance

Teclistamab

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
Tecvayli	90 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 22818.30	Biological · Prescription	Janssen-Cilag International NV	Valid
Tecvayli	10 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 4474.25	Biological · Prescription	Janssen-Cilag International NV	Valid

Indications — CHI Daman Drug Formulary

MULTIPLE MYELOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
TECVAYLI	30MG/3ML(10MG/ML); 153MG/1.7ML(90MG/ML)	injectable · injection	JANSSEN BIOTECH	Prescription	25 Oct 2022

EMA European Union — centrally authorised medicines

Tecvayli · Authorised · authorised 23 Aug 2022 · ATC L01FX24

Therapeutic indication (EMA)

Tecvayli is indicated in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy 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
TECVAYLI	02539756	30 MG / 3 ML	SOLUTION · SUBCUTANEOUS	JANSSEN INC
TECVAYLI	02539764	153 MG / 1.7 ML	SOLUTION · SUBCUTANEOUS	JANSSEN INC

Safety signals and safety-related labeling changes

US FDA 5 Mar 2026 TECVAYLI — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for teclistamab →

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.