Basic Information
Trydonis
Regulatory Information
EMEA/H/C/004702
April 26, 2018
8
November 4, 2024
Company Information
Italy
Via Palermo 26/A 43122 Parma
CHIESI FARMACEUTICI S.P.A.
Active Substances Detail
Beclometasone dipropionateformoterol fumarate dihydrateglycopyrronium
EMA Resources
Detailed Information
Therapeutic Indication
### 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).
Overview Summary
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.