Trimbow
beclometasone / formoterol / glycopyrronium bromide
Table of contents
Overview
Trimbow is a medicine used in adults for treating moderate to severe chronic obstructive pulmonary disease (COPD) and asthma.
In COPD, Trimbow is used for maintenance (continuing) treatment in patients whose disease is not adequately controlled despite treatment with a combination of two medicines consisting of a long-acting beta-2 agonist plus either an inhaled corticosteroid or a long-acting muscarinic receptor antagonist. Beta-2 agonists and muscarinic receptor antagonists help to widen the airways; corticosteroids reduce inflammation in the airways and lungs.
In asthma, Trimbow is used for maintenance treatment in adults whose disease is not adequately controlled despite treatment with a long-acting beta-2 agonist plus a medium or high dose of inhaled corticosteroid, and who had one or more exacerbations (flare-ups) in the past year.
Trimbow contains the active substances beclometasone, formoterol and glycopyrronium bromide.
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List item
Trimbow : EPAR - Medicine overview (PDF/132.54 KB)
First published: 09/08/2017
Last updated: 26/02/2021
EMA/24550/2019 -
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List item
Trimbow : EPAR - Risk-management-plan summary (PDF/115.27 KB)
First published: 20/03/2019
Last updated: 09/04/2021
Authorisation details
Product details | |
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Name |
Trimbow
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Agency product number |
EMEA/H/C/004257
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Pulmonary Disease, Chronic Obstructive
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Anatomical therapeutic chemical (ATC) code |
R03AL09
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Publication details | |
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Marketing-authorisation holder |
Chiesi Farmaceutici S.p.A.
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Revision |
7
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Date of issue of marketing authorisation valid throughout the European Union |
17/07/2017
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Contact address |
Via Palermo 26/A |
Product information
24/03/2022 Trimbow - EMEA/H/C/004257 - R/0025
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
Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.
COPD
Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1).
Asthma
Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.
Assessment history
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 November 202013/11/2020
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14/12/2018
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19/05/2017