Bevespi Aerosphere
glycopyrronium / formoterol fumarate dihydrate
Table of contents
Overview
Bevespi Aerosphere is a medicine used in adults to relieve the symptoms of chronic obstructive pulmonary disease (COPD). COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.
Bevespi Aerosphere is used for maintenance (regular) treatment. It contains the active substances glycopyrronium bromide and formoterol.
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List item
Bevespi Aerosphere : EPAR - Medicine overview (PDF/74.48 KB)
First published: 05/02/2019
EMA/752588/2018 -
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List item
Bevespi Aerosphere : EPAR - Risk-management-plan summary (PDF/317.57 KB)
First published: 05/02/2019
Authorisation details
Product details | |
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Name |
Bevespi Aerosphere
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Agency product number |
EMEA/H/C/004245
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Active substance |
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International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Pulmonary Disease, Chronic Obstructive
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Anatomical therapeutic chemical (ATC) code |
R03AL07
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Publication details | |
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Marketing-authorisation holder |
AstraZeneca AB
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Revision |
6
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Date of issue of marketing authorisation valid throughout the European Union |
18/12/2018
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Contact address |
AstraZeneca AB |
Product information
15/09/2023 Bevespi Aerosphere - EMEA/H/C/004245 - R/0017
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
Therapeutic indication
Bevespi Aerosphere is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).