Is Teplizumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Teplizumab, including Tzield (1 mg/ml, Solution for injection, SAR 50275.50).

Is Teplizumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Teplizumab, including TZIELD (Prescription).

Is Teplizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Teplizumab: Teizeild.

Are there safety signals or safety updates for Teplizumab?

US FDA: 1 entry (latest 2026-04-20).

Active substance

Teplizumab

SFDA 1
US FDA 1
EMA 1
Health Canada 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
Tzield	1 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 50275.50	Biological · Prescription	SANOFI WINTHROP INDUSTRIE	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
TZIELD	2MG/2ML(1MG/ML)	injectable · injection	PROVENTION BIO INC	Prescription	17 Nov 2022

EMA European Union — centrally authorised medicines

Teizeild Sanofi Winthrop Industrie · Authorised · authorised 8 Jan 2026 · ATC A10XX01

Therapeutic indication (EMA)

Teizeild is indicated to delay the onset of stage 3 type 1 diabetes (T1D) in adult and paediatric patients 8 years of age and older with stage 2 T1D.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TZIELD	02557347	2 MG / 2 ML	SOLUTION · INTRAVENOUS	SANOFI-AVENTIS CANADA INC

Safety signals and safety-related labeling changes

US FDA 20 Apr 2026 TZIELD — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for teplizumab →

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.