Trelegy Ellipta

fluticasone furoate / umeclidinium / vilanterol

Opinion

On 20 September 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Trelegy Ellipta. The marketing authorisation holder for this medicinal product is GlaxoSmithKline Trading Services Limited.

The CHMP adopted an extension to the existing indication as follows1:

“Trelegy 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).”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold

Key facts

Name
Trelegy Ellipta
Agency product number
EMEA/H/C/004363
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
20/09/2018
Company name
GlaxoSmithKline Trading Services
Status
Positive
Application type
Post-authorisation

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