Bevespi Aerosphere

RSS

glycopyrronium / formoterol fumarate dihydrate

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

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.

This EPAR was last updated on 05/02/2019

Authorisation details

Product details
Name
Bevespi Aerosphere
Agency product number
EMEA/H/C/004245
Active substance
glycopyrronium / formoterol fumarate dihydrate
International non-proprietary name (INN) or common name
glycopyrronium / formoterol fumarate dihydrate
Therapeutic area (MeSH)
Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code
R03AL07
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
Date of issue of marketing authorisation valid throughout the European Union
18/12/2018
Contact address

AstraZeneca AB
Sodertalje
SE-151 85 Sodertalje
Sweden

Product information

Bevespi Aerosphere - EMEA/H/C/004245 -

Contents

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Pharmacotherapeutic group

formoterol and glycopyrronium bromide

Therapeutic indication

Bevespi Aerosphere is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Assessment history

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