Trydonis

RSS

beclometasone / formoterol / glycopyrronium bromide

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

Overview

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.

This EPAR was last updated on 02/05/2018

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
0
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

26/04/2018 Trydonis - EMEA/H/C/004702 -

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

Assessment history

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