Elebrato Ellipta

fluticasone furoate / umeclidinium / vilanterol

Table of contents

Opinion

The European Medicines Agency has recommended the refusal of a change to the marketing authorisation for Elebrato Ellipta. The change concerned an extension of indication to add treatment of patients with asthma.

The Agency issued this opinion on 25 February 2021.

The company that applied for the change to the authorisation, GlaxoSmithKline Trading Services Limited, may ask for re-examination of the opinion within 15 days of receiving the opinion.

Key facts

Name
Elebrato Ellipta
Agency product number
EMEA/H/C/004781
International non-proprietary name (INN) or common name
  • fluticasone furoate
  • umeclidinium
  • vilanterol
Active substance
  • fluticasone furoate
  • umeclidinium bromide
  • vilanterol trifenatate
Therapeutic area
Pulmonary Disease, Chronic Obstructive
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.

Date opinion adopted
25/02/2021
Company name
GlaxoSmithKline Trading Services Limited
Status
Negative
Application type
Post-authorisation

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