Tezspire
tezepelumab
Table of contents
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.
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List item
Tezspire : EPAR - Medicine overview (PDF/150.66 KB)
First published: 21/09/2022
EMEA/H/C/005588 -
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List item
Tezspire : EPAR - Risk-management-plan (PDF/717.95 KB)
First published: 21/09/2022
Last updated: 20/02/2023
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 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 | |
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Marketing-authorisation holder |
AstraZeneca AB
|
Revision |
8
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Date of issue of marketing authorisation valid throughout the European Union |
19/09/2022
|
Contact address |
151 85 Sodertalje |
Product information
06/10/2023 Tezspire - EMEA/H/C/005588 - IAIN/0011
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.