Trelegy Ellipta
fluticasone furoate / umeclidinium / vilanterol
Table of contents
Overview
Trelegy Ellipta is a medicine used 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.
Trelegy Ellipta is used in adults whose disease is not controlled well enough with a combination of inhaled medicines consisting of a long-acting beta-2 agonist plus either a corticosteroid or a long-acting muscarinic antagonist. Long-acting beta-2 agonists widen the airways; corticosteroids reduce inflammation in the airways and lungs; and muscarinic receptor antagonists cause the muscles of the airways to relax.
Trelegy Ellipta is used for maintenance (regular) treatment on a daily basis. It contains the active substances fluticasone furoate, umeclidinium bromide and vilanterol.
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List item
Trelegy Ellipta : EPAR - Medicine overview (PDF/70.63 KB)
First published: 12/01/2018
Last updated: 04/01/2019 -
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List item
Trelegy Ellipta : EPAR - Risk-management-plan summary (PDF/2.53 MB)
First published: 04/01/2019
Authorisation details
Product details | |
---|---|
Name |
Trelegy Ellipta
|
Agency product number |
EMEA/H/C/004363
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Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Pulmonary Disease, Chronic Obstructive
|
Anatomical therapeutic chemical (ATC) code |
R03AL08
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Publication details | |
---|---|
Marketing-authorisation holder |
GlaxoSmithKline Trading Services
|
Revision |
10
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Date of issue of marketing authorisation valid throughout the European Union |
15/11/2017
|
Contact address |
12 Riverwalk |
Product information
16/02/2023 Trelegy Ellipta - EMEA/H/C/004363 - WS/2358
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Trelegy Ellipta is indicated as a 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 β2-agonist.