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 to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD). COPD is a long-term disease in which the airways and air sacs in the lungs become damaged or blocked, leading to difficulty breathing.

Trimbow is used for maintenance (regular) treatment in patients whose disease is not adequately controlled despite treatment with a combination of two COPD medicines consisting of a beta-2 agonist plus either an inhaled corticosteroid or a long-acting muscarinic antagonist. Long-acting beta-2 agonists and muscarinic receptor antagonists help to widen the airways; corticosteroids reduce inflammation in the airways and lungs.

Trimbow contains the active substances beclometasone, formoterol and glycopyrronium bromide.

This EPAR was last updated on 20/03/2019

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
1
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

23/01/2019 Trimbow - EMEA/H/C/004257 - II/0002

Contents

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Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

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).

Assessment history

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