Trimbow

RSS

beclometasone / formoterol / glycopyrronium bromide

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

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.

This EPAR was last updated on 09/04/2021

Authorisation details

Product details
Name
Trimbow
Agency product number
EMEA/H/C/004257
Active substance
  • Beclometasone dipropionate
  • formoterol fumarate dihydrate
  • glycopyrronium bromide
International non-proprietary name (INN) or common name
  • beclometasone
  • formoterol
  • glycopyrronium bromide
Therapeutic area (MeSH)
Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code
R03AL09
Publication details
Marketing-authorisation holder
Chiesi Farmaceutici S.p.A.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
17/07/2017
Contact address

Via Palermo 26/A
43122 Parma
Italy

Product information

07/04/2021 Trimbow - EMEA/H/C/004257 - X/0012

Contents

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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

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