Is Teprotumumab 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 Teprotumumab, including Tepezza (500 mg, Intravenous infusion, SAR 63245.05).

Is Teprotumumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Teprotumumab, including TEPEZZA (Prescription).

Is Teprotumumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Teprotumumab: Tepezza.

Are there safety signals or safety updates for Teprotumumab?

US FDA: 1 entry (latest 2026-09-23).

Active substance

Teprotumumab

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
Tepezza	500 mg	Intravenous infusion · Intravenous use	1 Vial	SAR 63245.05	Biological · Prescription	Horizon Therapeutics DAC	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
TEPEZZA	500MG	injectable · injection	HORIZON THERAPEUTICS IRELAND	Prescription	21 Jan 2020

EMA European Union — centrally authorised medicines

Tepezza Amgen Europe B.V. · Authorised · authorised 19 Jun 2025 · ATC L04AG13

Therapeutic indication (EMA)

Treatment of moderate to severe thyroid eye disease (TED).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TEPEZZA	02557061	500 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	AMGEN CANADA INC

Safety signals and safety-related labeling changes

US FDA 23 Sep 2026 TEPEZZA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for teprotumumab →

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.