Temybric Ellipta

RSS

fluticasone furoate / umeclidinium / vilanterol

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

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 Limited
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
12/06/2019
Contact address

12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland

Product information

11/12/2021 Temybric Ellipta - EMEA/H/C/005254 - WS/2130/G

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Product information documents contain:

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

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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