Temybric Ellipta

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fluticasone furoate / umeclidinium / vilanterol

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

Overview

Temybric 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 in the lungs become damaged or blocked, leading to difficulty breathing.

Temybric 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 and muscarinic receptor antagonists cause the muscles of the airways to relax which leads to a widening of the airways. Corticosteroids reduce inflammation in the airways and lungs.

Temybric Ellipta is used for maintenance (regular) treatment on a daily basis. It contains the active substances fluticasone furoate, umeclidinium bromide and vilanterol.

This medicine is the same as Trelegy Ellipta, which is already authorised in the EU. The company that makes Trelegy Ellipta has agreed that its scientific data can be used for Temybric Ellipta (‘informed consent’).

This EPAR was last updated on 23/09/2019

Authorisation details

Product details
Name
Temybric Ellipta
Agency product number
EMEA/H/C/005254
Active substance
  • fluticasone furoate
  • umeclidinium bromide
  • vilanterol trifenatate
International non-proprietary name (INN) or common name
  • fluticasone furoate
  • umeclidinium
  • vilanterol
Therapeutic area (MeSH)
Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code
R03AL08
Additional monitoringAdditional 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
Marketing-authorisation holder
GlaxoSmithKline Trading Services
Date of issue of marketing authorisation valid throughout the European Union
12/06/2019
Contact address

Currabinny
Carrigaline
County Cork
Ireland

Product information

Temybric Ellipta - EMEA/H/C/005254 -

Contents

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Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Temybric 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 or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1).

Assessment history

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