Temybric Ellipta

Withdrawn

This medicine's authorisation has been withdrawn

fluticasone furoate / umeclidinium / vilanterol

Overview

The marketing authorisation for Temybric Ellipta has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.

Temybric Ellipta : EPAR - Medicine overview

Reference Number: EMA/247773/2019

Temybric Ellipta : EPAR - Risk-management-plan summary

Product information

Temybric Ellipta : EPAR - Product Information

Latest procedure affecting product information: WS/2130/G

11/12/2021

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).

Temybric Ellipta : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Temybric Ellipta
• 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

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 ?2-agonist or a combination of a long-acting ?2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1).

Authorisation details

• EMA product number:
  EMEA/H/C/005254
• Marketing authorisation holder:
  GlaxoSmithKline Trading Services Limited

  12 Riverwalk; Citywest Business Campus; Dublin 24; D24 YK11; Ireland

• Marketing authorisation issued:
  12/06/2019
• Revision:
  4

Assessment history

Changes since initial authorisation of medicine

Temybric Ellipta : EPAR - Procedural steps taken and scientific information after the authorisation

Questions and answers on the refusal of a change to the marketing authorisation for Temybric Ellipta (fluticasone furoate / umeclidinium / vilanterol)

AdoptedReference Number: EMA/126142/2021

Initial marketing authorisation documents

Temybric Ellipta : EPAR - Public assessment report

AdoptedReference Number: EMA/299628/2019

CHMP summary of positive opinion for Temybric Ellipta

AdoptedReference Number: EMA/CHMP/228757/2019