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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Trelegy Ellipta : EPAR - Risk-management-plan summary (PDF/170.13 KB)
First published: 04/01/2019
Authorisation details
Product details | |
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Name |
Trelegy Ellipta
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Agency product number |
EMEA/H/C/004363
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Pulmonary Disease, Chronic Obstructive
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Anatomical therapeutic chemical (ATC) code |
R03AL08
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Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
GlaxoSmithKline Trading Services
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Revision |
6
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Date of issue of marketing authorisation valid throughout the European Union |
15/11/2017
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Contact address |
Product information
10/09/2020 Trelegy Ellipta - EMEA/H/C/004363 - WS/1814
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
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.