Tezspire

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tezepelumab

Authorised
This medicine is authorised for use in the European Union.

Overview

Tezspire is a medicine used to treat adults and adolescents (12 years of age and older) with severe asthma. It is used as an additional treatment in adults and adolescents with severe asthma that is not adequately controlled by a combination of high-dose corticosteroids taken by inhalation plus another asthma medicine.

Tezspire contains the active substance tezepelumab.

This EPAR was last updated on 09/10/2023

Authorisation details

Product details
Name
Tezspire
Agency product number
EMEA/H/C/005588
Active substance
tezepelumab
International non-proprietary name (INN) or common name
tezepelumab
Therapeutic area (MeSH)
Asthma
Anatomical therapeutic chemical (ATC) code
R03DX11
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
19/09/2022
Contact address

151 85 Sodertalje
Sweden

Product information

06/10/2023 Tezspire - EMEA/H/C/005588 - IAIN/0011

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Tezspire 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.

Assessment history

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