Temybric Ellipta

Lapsed

This medicine's authorisation has lapsed

fluticasone furoate / umeclidinium / vilanterol

Overview

On 14 June 2022, the marketing authorisation of Temybric Ellipta (fluticasone furoate / umeclidinium / vilanterol) ceased to be valid in the European Union (EU). The cessation of validity is due to the fact that the marketing authorisation holder, GlaxoSmithKline Trading Services Limited, had not marketed Temybric Ellipta in the EU since its initial marketing authorisation. 

In accordance with provisions of the sunset clause, the marketing authorisation of the medicinal product lapsed as the product had not been marketed in any of the EU Member States within three years of its initial authorisation. GlaxoSmithKline Trading Services Limited confirmed that the product had not been marketed due to commercial reasons. 

Temybric Ellipta was granted marketing authorisation in the EU on 12 June 2019 for treatment of adult patients with chronic obstructive pulmonary disease (COPD). The marketing authorisation was initially valid for a 5-year period. Temybric Ellipta was a duplicate application to Trelegy Ellipta, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Trelegy Ellipta and its other duplicate Elebrato Ellipta. 

The European Public Assessment Report (EPAR) for Temybric Ellipta is updated to indicate that the marketing authorisation is no longer valid.

Temybric Ellipta : EPAR - Medicine overview

Reference Number: EMA/247773/2019

Temybric Ellipta : EPAR - Risk-management-plan summary

Product information

Temybric Ellipta : EPAR - Product Information

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
• Lapse of marketing authorisation:
  14/06/2022
• 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)

Adopted Reference Number: EMA/126142/2021

Initial marketing authorisation documents

Temybric Ellipta : EPAR - Public assessment report

Adopted Reference Number: EMA/299628/2019

CHMP summary of positive opinion for Temybric Ellipta

Adopted Reference Number: EMA/CHMP/228757/2019