Trimbow
beclometasone / formoterol / glycopyrronium bromide
Table of contents
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.
-
List item
Trimbow : EPAR - Medicine overview (PDF/78.71 KB)
First published: 09/08/2017
Last updated: 20/03/2019
EMA/24550/2019 -
List item
Trimbow : EPAR - Risk-management-plan summary (PDF/313.17 KB)
First published: 20/03/2019
Authorisation details
Product details | |
---|---|
Name |
Trimbow
|
Agency product number |
EMEA/H/C/004257
|
Active substance |
|
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 |
Product information
23/01/2019 Trimbow - EMEA/H/C/004257 - II/0002
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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).