Trydonis

RSS

beclometasone / formoterol / glycopyrronium bromide

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

Overview

Trydonis 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 inside the lungs become damaged or blocked, leading to difficulty breathing.

Trydonis is used for maintenance (continuing) treatment in patients whose disease is not adequately controlled despite treatment with a combination of two COPD 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.

This medicine is the same as Trimbow, which is already authorised in the EU. The company that makes Trimbow has agreed that its scientific data can be used for Trydonis (‘informed consent’).

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

This EPAR was last updated on 04/07/2023

Authorisation details

Product details
Name
Trydonis
Agency product number
EMEA/H/C/004702
Active substance
  • Beclometasone dipropionate
  • formoterol fumarate dihydrate
  • glycopyrronium
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
26/04/2018
Contact address

Via Palermo 26/A
43122 Parma
Italy

Product information

02/12/2022 Trydonis - EMEA/H/C/004702 - R/0025

Other EU languages available icon 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:

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 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

How useful was this page?

Add your rating
Average
1 rating