Trydonis

beclometasone / formoterol / glycopyrronium bromide

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About

An overview of Trydonis and why it is authorised in the EU

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 (regular) treatment in patients whose disease is not adequately controlled despite treatment with a combination of two other COPD medicines, a beta-2 agonist and an inhaled corticosteroid.

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.

How is Trydonis used?

Trydonis is available as a liquid in a portable inhaler device. Each inhalation provides a fixed dose of the medicine. The recommended dose is two inhalations twice a day.

Patients should be shown how to use the inhaler correctly by a doctor or other healthcare professional, who should also regularly check that the patient’s inhalation technique is correct.

The medicine can only be obtained with a prescription. For more information about using Trydonis, see the package leaflet or contact your doctor or pharmacist.

How does Trydonis work?

The three active substances in Trydonis work by reducing inflammation and keeping the airways open by various mechanisms, so allowing the patient to breathe more easily.

Beclometasone belongs to a group of anti-inflammatory medicines known as corticosteroids. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors (targets) in various types of immune cell. This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.

Formoterol is a long-acting beta-2 agonist. It works by attaching to receptors known as beta-2 receptors found in the muscles of the airways. When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient’s breathing.

Glycopyrronium bromide is a muscarinic receptor antagonist. This means that it opens the airways in another way, by blocking muscarinic receptors in muscle cells in the lungs. Because these receptors help control the contraction of muscles, when glycopyrronium is inhaled, it causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.

What benefits of Trydonis have been shown in studies?

Trydonis has been shown to be effective at relieving symptoms of COPD in two main studies involving over 4,000 patients whose symptoms were not adequately controlled with a combination of two other COPD medicines.

In the first study at 26 weeks, Trydonis improved patients’ FEV1 (the maximum volume of air a person can breathe out in one second) by 82 ml before a dose and 261 ml after a dose. This was more than increases of 1 and 145 ml respectively in patients treated with a medicine containing only 2 of the active substances found in Trydonis (beclometasone plus formoterol).

In the second study, patients treated with Trydonis had 20% fewer exacerbations (flare-ups of symptoms) per year than patients treated with tiotropium (a muscarinic receptor antagonist). In this study, Trydonis also had a comparable effect on reducing the number of exacerbations to a combination of tiotropium, beclometasone and formoterol.

What are the risks associated with Trydonis?

Side effects with Trydonis include oral candidiasis (a fungal infection of the mouth caused by a yeast called Candida), muscles spasms and dry mouth.

For the full list of all side effects and restrictions with Trydonis, see the package leaflet.

Why is Trydonis authorised in the EU?

Trydonis is effective at reducing the frequency of exacerbations and improving lung function of patients with COPD. No major safety concerns have been reported with Trydonis, with side effects being manageable and similar to other COPD medicines. The European Medicines Agency therefore decided that Trydonis’s benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Trydonis?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trydonis have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Trydonis is continuously monitored. Side effects reported with Trydonis are carefully evaluated and any necessary action taken to protect patients.

Other information about Trydonis

Trydonis received a marketing authorisation valid throughout the EU on 26 April 2018.

Name Language First published Last updated
Trydonis : EPAR - Summary for the public BG = bălgarski 2018-05-02  
Trydonis : EPAR - Summary for the public ES = español 2018-05-02  
Trydonis : EPAR - Summary for the public CS = čeština 2018-05-02  
Trydonis : EPAR - Summary for the public DA = dansk 2018-05-02  
Trydonis : EPAR - Summary for the public DE = Deutsch 2018-05-02  
Trydonis : EPAR - Summary for the public ET = eesti keel 2018-05-02  
Trydonis : EPAR - Summary for the public EL = elliniká 2018-05-02  
Trydonis : EPAR - Summary for the public EN = English 2018-05-02  
Trydonis : EPAR - Summary for the public FR = français 2018-05-02  
Trydonis : EPAR - Summary for the public IT = italiano 2018-05-02  
Trydonis : EPAR - Summary for the public LV = latviešu valoda 2018-05-02  
Trydonis : EPAR - Summary for the public LT = lietuvių kalba 2018-05-02  
Trydonis : EPAR - Summary for the public HU = magyar 2018-05-02  
Trydonis : EPAR - Summary for the public MT = Malti 2018-05-02  
Trydonis : EPAR - Summary for the public NL = Nederlands 2018-05-02  
Trydonis : EPAR - Summary for the public PL = polski 2018-05-02  
Trydonis : EPAR - Summary for the public PT = português 2018-05-02  
Trydonis : EPAR - Summary for the public RO = română 2018-05-02  
Trydonis : EPAR - Summary for the public SK = slovenčina 2018-05-02  
Trydonis : EPAR - Summary for the public SL = slovenščina 2018-05-02  
Trydonis : EPAR - Summary for the public FI = suomi 2018-05-02  
Trydonis : EPAR - Summary for the public SV = svenska 2018-05-02  
Trydonis : EPAR - Summary for the public HR = Hrvatski 2018-05-02  

This EPAR was last updated on 02/05/2018 .

Authorisation details

Product details

Product details for Trydonis
NameTrydonis
Agency product numberEMEA/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 Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code R03AL09

Publication details

Publication details for Trydonis
Marketing-authorisation holder

Chiesi Farmaceutici S.p.A.

Revision0
Date of issue of marketing authorisation valid throughout the European Union26/04/2018

Contact address:

Via Palermo 26/A
43122 Parma
Italy

Product information

Product information

26/04/2018  Trydonis -EMEA/H/C/004702

Name Language First published Last updated
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  
Trydonis : EPAR - Product Information HR = Hrvatski 2018-05-02  

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.


Name Language First published Last updated
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  
Trydonis : EPAR - All Authorised presentations HR = Hrvatski 2018-05-02  

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

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Trydonis : EPAR - Public assessment report HR = Hrvatski 2018-05-02  
CHMP summary of positive opinion for Trydonis HR = Hrvatski 2018-02-23  

Authorised

This medicine is approved for use in the European Union