Is Tezepelumab 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 Tezepelumab, including Tezspire 210 mg per 1.9 ml Pre-filled syringe (110 mg/ml, Solution for injection, SAR 5804.95); Tezspire 210 mg per 1.9 ml pen (110 mg/ml, Solution for injection, SAR 5804.95).

Is Tezepelumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Tezepelumab, including TEZSPIRE (Prescription).

Is Tezepelumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tezepelumab: Tezspire.

Are there safety signals or safety updates for Tezepelumab?

US FDA: 1 entry (latest 2025-10-17).

Active substance

Tezepelumab

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
Tezspire 210 mg per 1.9 ml Pre-filled syringe	110 mg/ml	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 5804.95	Biological · Prescription	AstraZeneca AB	Valid
Tezspire 210 mg per 1.9 ml pen	110 mg/ml	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 5804.95	Biological · Prescription	AstraZeneca AB	Valid

Indications — CHI Daman Drug Formulary

ASTHMA

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

Product	Strength	Form · route	Applicant	Status	First approved
TEZSPIRE	210MG/1.91ML(110MG/ML)	solution · subcutaneous	ASTRAZENECA AB	Prescription	17 Dec 2021

EMA European Union — centrally authorised medicines

Tezspire AstraZeneca AB · Authorised · authorised 19 Sep 2022 · ATC R03DX11

Therapeutic indication (EMA)

AsthmaTezspire is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment. Chronic rhinosinusitis with nasal polyps (CRSwNP) Tezspire is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids, and/or surgery do not provide adequate disease control.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TEZSPIRE	02529548	110 MG / ML	SOLUTION · SUBCUTANEOUS	ASTRAZENECA CANADA INC
TEZSPIRE	02529556	110 MG / ML	SOLUTION · SUBCUTANEOUS	ASTRAZENECA CANADA INC

Safety signals and safety-related labeling changes

US FDA 17 Oct 2025 TEZSPIRE — 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 tezepelumab →

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.