Trimbow

RSS

beclometasone / formoterol / glycopyrronium bromide

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

Overview

This is a summary of the European public assessment report (EPAR) for Trimbow. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Trimbow.

For practical information about using Trimbow, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 09/08/2017

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
R03
Publication details
Marketing-authorisation holder
Chiesi Farmaceutici S.p.A.
Revision
0
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

17/07/2017 Trimbow - EMEA/H/C/004257 - -

Contents

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 (for effects on symptoms control and prevention of exacerbations see section 5.1).

Assessment history

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